Search Results - EGA European Genome-Phenome Archive

Proteogenomic Studies to Understand Mechanisms and Drivers of Resistance to Immunotherapies

Immune checkpoint inhibitors (ICIs) targeting programmed death (PD-1) and cytotoxic T lymphocyte-associated protein 4 (CTLA-4) produce durable responses in advanced cutaneous melanoma, yet reliable predictive biomarkers remain elusive. We performed a multi-cohort proteogenomic investigation of pre-treatment formalin-fixed paraffin-embedded (FFPE) biopsies from patients with metastatic cutaneous melanoma who later underwent either dual PD-1+CTLA-4 ICI therapy or PD-1 ICI monotherapy. Melanoma metastases of the lung, lymph node, and skin from the 3 cohorts were collected from 12 study sites in the United States, Europe, and Australia, comprising two separate PD-1+CTLA-4 ICI-treated discovery and validation cohorts ("Discovery Cohort" and "Validation Cohort 1", n=164 samples), and one PD-1 ICI monotherapy-treated validation cohort ("Validation Cohort 2", n=44 samples). Comprehensive genomic profiling was performed across the Discovery and two Validation Cohorts (across 180 individual samples) using Ribo-Erase total RNA sequencing (RNA-seq) (data generated for 173 samples), low-pass whole-genome sequencing (lpWGS) for the purpose of detecting somatic copy-number alterations (data generated for 177 samples), and a custom melanoma-focused targeted DNA sequencing panel (comprised of 86 genes, ~0.75Mb) designed to maximize the sensitivity of detecting recurrent and clinically actionable mutations (data generated for 175 samples). Pathway-level proteomic clustering identified three tumor subtypes; ICI-sensitive (immune-inflamed), ribosome-high (translationally active), and epithelial-mesenchymal transition (EMT)-like (stromal-enriched) that were reproducibly validated and showed significant PFS differences (p = 0.02–0.03) across cohorts. Subtype–outcome associations were consistent with previous immunotherapy datasets, with pooled hazard ratios ~0.5–0.8 for immune-enriched tumors. Additionally, we identified a 127-protein classifier that outperformed previously reported genomic signatures, suggesting that proteomic subtyping captured clinically relevant biology not accessible via genomics or transcriptomics alone. Our results identify potential new therapeutic vulnerabilities and lay the foundation for biomarker-driven patient stratification in combination ICI trials. Proteomic data will be made available through the National Cancer Institute's Proteomic Data Commons repository.

Study phs004511

Childhood Cancer Data Initiative (CCDI): Admixture Analysis of Acute Lymphoblastic Leukemia in African American Children: The ADMIRAL Study

Children with substantial African ancestry are observed to have less than half the incidence of B-cell acute lymphoblastic leukemia (B-ALL) than children of other continental ancestries. The Admixture Analysis of Acute Lymphoblastic Leukemia in African American Children study (ADMIRAL) was designed to investigate genes and loci that explain the unique risk profile of African American children. Germline DNA samples were obtained from Children's Oncology Group frontline protocols, the Michigan BioTrust for Health, and various academic hospital ALL banks. Cases represented a diagnosis of B-ALL between the ages of 0-20 years, and controls were matched on birth year, sex, and maternal race/ethnicity. All participants have reported Black/African American race or substantial inferred African genetic ancestry. Altogether, 840 cases and 392 internal controls are included in this submission. All samples were genotyped on the Illumina Global Diversity Array 8v1. Phenotype information includes case/control status and reported sex.

Study phs004222

Southern Community Cohort Study - the Gut Microbiome Project

The Southern Community Cohort Study (SCCS) is an ongoing prospective cohort study, with the aim to investigate risk factors of cancer and other chronic diseases across 12 southeastern U.S. states: Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia. Approximately 86,000 adults, two-thirds Black people, between 40 and 79 years of age were enrolled from 2002 to 2009. Approximately 86% of the participants were recruited from community health centers (CHCs) and institutions providing basic health care and preventative services in underserved areas, so the cohort encompassed a substantial number of individuals characterized by low income, low education, and lack of insurance. The remaining 14% of cohort participants were recruited through mail-based general population sampling. Sociodemographic characteristics, lifestyle factors including tobacco exposure and alcohol consumption, and personal medical history were collected at cohort enrollment. Data collection methods varied by recruitment source: CHC participants completed standardized computer-assisted personal interviews, while individuals from the general population responded to self-administered mailed questionnaires. The SCCS Biospecimen Repository includes blood samples from ~40,000, mouth cells from 39,000, urines from 24,000, stool specimens from 8,000 participants, and tumor blocks from incident cancer cases. This microbiome study nested within SCCS included 594 Black participants whose stool samples were analyzed using shotgun metagenomic sequencing. We investigated associations between the gut microbiome and several physical activity measures.

Study phs004716

Transcriptome of Human Merkel Cell Carcinoma

Merkel Cell Carcinoma (MCC) is a rare and aggressive skin cancer with poorly understood molecular characteristics. In this study, we conducted RNA sequencing (RNA-Seq) on tumor samples from 9 human MCC patients to unravel the intricate transcriptional landscape of MCC. Data available in dbGaP include bulk RNA sequencing of 9 tumor samples.

Study phs003411

NCTN: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma (E2805)

Study ID: E2805 NCT Number: NCT00326898 ECOG-ACRIN Cancer Research Group Submitted in collaboration with the NCTN/NCORP Data Archive Trial Title: NCTN: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma (E2805) Trial Description: This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer. Clinical data presented in the following publication(s): • PMID 26969090 • PMID 30130544 • PMID 31471309 • Additional unpublished data from E2805 Disease type(s): Kidney Neoplasm - Renal Cell Carcinoma Clinical Dataset(s) included: • NCT00326898-D1 (PMID 26969090): There are two datasets for E2805's primary publication 26969090 (-D1 and -D2). This dataset, NCT00326898-D1, contains baseline characteristics, stratification factors, treatment dose, number of cycles received, surgery type (radical or partial nephrectomy), and outcome data. Patient ID 1410 corresponds to a duplicate registration for which no data was collected and therefore excluded. NCT00326898-D2 contains toxicity data. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs. • NCT00326898-D2 (PMID 26969090): There are two datasets for E2805's primary publication 26969090 (-D1 and -D2). This dataset, NCT00326898-D2, contains toxicity data. NCT00326898-D1 contains baseline characteristics, stratification factors, treatment dose, number of cycles received, surgery type (radical or partial nephrectomy), and outcome data. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs. • NCT00326898-D3 (Unpublished data): This dataset, NCT00326898-D3, contains data collected on ECOG-ACRIN trial E2805, which are not published in the primary, nonclear cell renal cell carcinoma cohort, or cytokine analysis publication for the trial. NCT00326898-D3 includes information on arm A (Sunitinib) and arm B (Sorafenib) patients that started treatment for E2805 study. The dataset contains information on the time interval from randomization to treatment start date, treatment dose, and reasons for dose modification by cycle. Treatment arm information can be found in D1. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs. • NCT00326898-D4 (Unpublished data): This dataset, NCT00326898-D4, contains data collected on ECOG-ACRIN trial E2805, which are not published in the primary, nonclear cell renal cell carcinoma cohort, or cytokine analysis publication for the trial. NCT00326898-D4 contains toxicity data (by cycle) on hypertension, diarrhea, hand-foot reaction, and/or rash/desquamation while on treatment for E2805 study, including treatment attribution and time interval from randomization to toxicity start date. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs. Treatment arm information can be found in D1. • NCT00326898-D5 (PMID 30130544): There is one dataset for PMID 30130544 (-D5). This dataset, NCT00326898-D5, contains the analysis data published in PMID 30130544, a publication focusing on the nonccRCC subgroup of ECOG-ACRIN trial E2805. This dataset contains recurrence site data, competing risk indicators, and updated survival times. Variables reported in this publication such as age, sex, treatment arm, and histology are identical to those presented in NCT00326898-D1 (for the trial's primary publication, PMID 26969090) and are thus not duplicated in this dataset. NCT00326898-D5 can be used together with the NCT00326898-D6 dataset to obtain updated, complete information on sites of recurrence. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs.• NCT00326898-D6 (Unpublished data): This dataset, NCT00326898-D6, contains data collected on ECOG-ACRIN trial E2805, which are not published in the primary, nonclear cell renal cell carcinoma cohort, or cytokine analysis publication for the trial. NCT00326898-D6 contains information (the time interval from nephrectomy to randomisation, cause of death, histology components, and clarification about what sites the "other" and "other organs" (-D5) include for sites of recurrence) collected on the trial but not published. Both NCT00326898-D5 and NCT00326898-D6 datasets together provide updated, complete information on sites of recurrence. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs. COD data is consistent with survival information presented in D5. • NCT00326898-D7 (PMID 31471309): There is one dataset for PMID 31471309 (-D7). This dataset contains the cytokine analysis data published in PMID 31471309 based on trial NCT00326898. Variables reported in this publication such as treatment arm, T-stage, Fuhrman grade, ECOG PS, DFS, and DFS event are identical to those presented in NCT00326898-D1 (for the trial's primary publication, PMID 26969090) and are thus not duplicated in this dataset. You are encouraged to view the PDF data dictionaries found in the "Documents" tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

Study phs004235

Subtyping of Small Cell Lung Cancer Using ChIP-Seq of Plasma Cell-Free Nucleosomes and Matched Tumor Transcriptomes

We undertook an observational study using plasma collected from patients with small cell cancer who received care at the National Cancer Institute (NCI). Human subjects committee at NCI approved the studies; all patients provided written informed consent for plasma, tumor, and matched normal sample sequencing. Sequence data for 8 samples in phs003628 are available under phs004200.

Study phs003628

Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT-BioLINCC)

Data Access NOTE: Please refer to the “Authorized Access” section below for information about how access to the data from this accession differs from many other dbGaP accessions. ObjectivesTo determine whether pharmacomechanical thrombolysis prevents post-thrombotic syndrome in patients with proximal deep-vein thrombosis.BackgroundDespite the use of anticoagulant therapy, post-thrombotic syndrome develops within 2 years in approximately half of patients with proximal deep-vein thrombosis (DVT). Small randomized trials have suggested that active removal of acute thrombus may preserve venous function and prevent post-thrombotic syndrome.Pharmacomechanical catheter-directed thrombolysis (hereafter “pharmacomechanical thrombolysis”) is the delivery of a fibrinolytic drug into the thrombus with concomitant thrombus aspiration or maceration. This method is thought to be safer, more effective, and more efficient than previous methods. However, the question of whether this method improves long-term DVT patient outcomes with acceptable risk and cost had not yet been addressed.ParticipantsPatients with symptomatic proximal deep-vein thrombosis involving the femoral, common femoral, or iliac vein (with or without other involved ipsilateral veins) were enrolled at 56 clinical centers in the United States. Patients were excluded if they were younger than 16 or older than 75 years of age, were pregnant, had had symptoms for more than 14 days, were at high bleeding risk, had active cancer, had established post-thrombotic syndrome, or had had ipsilateral deep-vein thrombosis in the previous 2 years.A total of 692 patients underwent randomization. 337 patients were assigned to the pharmacomechanical-thrombolysis group and 355 patients were assigned to the control group.DesignATTRACT was a phase 3, multicenter, randomized, open-label, assessor-blinded, controlled clinical trial. Patients were randomly assigned in a 1:1 ratio to the pharmacomechanical-thrombolysis group or the control group. Randomization was stratified according to clinical center and thrombus extent. Patients in each treatment group received initial and long-term anticoagulant therapy consistent with published guidelines and were provided sized-to-fit, knee-high, elastic compression stockings providing 30 to 40 mm Hg of pressure at the 10-day follow-up visit and every 6 months.For patients in the pharmacomechanical-thrombolysis group, recombinant tissue plasminogen activator (rt-PA) at a dose of The severity of the post-thrombotic syndrome was evaluated at 6, 12, 18 and 24 months with the use of the Villalta scale and the Venous Clinical Severity Score (in both measures, higher scores indicating more severe post-thrombotic syndrome). Patient-reported health-related quality of life at baseline and 24 months was assessed with the use of the generic Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and the venous disease–specific Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) measure. Leg pain and leg swelling at baseline, 10 days, and 30 days were assessed with the use of a 7-point Likert pain scale (with higher scores indicating more severe pain) and by measuring calf circumference, respectively. Safety outcomes included bleeding, recurrent venous thromboembolism, and death, which were reported throughout follow-up and summarized through 10 days and 24 months. The clinical personnel who performed assessments of efficacy outcomes and the adjudicators of safety and efficacy outcomes were unaware of the treatment assignments.The primary outcome was development of post-thrombotic syndrome as defined by a Villalta score of 5 or higher or an ulcer in the leg with the index deep-vein thrombosis, at any time between the 6-month follow-up visit and the 24-month follow-up visit. Conclusions In conclusion, among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of post-thrombotic syndrome but did result in a higher risk of major bleeding (Vedantham S, Goldhaber SZ, Julian JA, et al., N Engl J Med. 2017;377(23):2240-2252).

Study phs004818

NCTN: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) under the Age of 4 Years (AAML0431)

Study ID: AAML0431NCT Number: NCT00369317 Children's Oncology Group (COG)Submitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) under the Age of 4 Years (AAML0431)Trial Description: This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Clinical data presented in the following publication(s):PMID 28389462 Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Myeloid LeukemiaHematopoietic Neoplasm/Leukemia - Myelodysplastic SyndromeClinical Dataset(s) included:NCT00369317-D1 (PMID 28389462): NCT00369317-D1 is the only dataset associated with AAML0431's primary publication 28389462. The dataset contains the CONSORT flow of patient enrollment, baseline characteristics, adverse events, MRD, cytogenetics, and primary outcome analyses for patients on AAML0431 as reported in the manuscript. Also, data for patients on A2971 are provided in order to compare brief baseline characteristics and outcome to patients on AAML0431.You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

Study phs004144

Dietary Intervention Study in Children Follow-Up Study (DISC06-BioLINCC)

Data Access NOTE: Please refer to the “Authorized Access” section below for information about how access to the data from this accession differs from many other dbGaP accessions. Access to Biospecimens is through the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Biospecimens from DISC06 include Plasma, Serum, and Whole Blood. Objectives: To examine the long-term effects of an intervention to lower fat intake among adolescent girls on biomarkers that are related to breast cancer risk in adults.Background: Although animal and ecologic studies have suggested a link between dietary fat and the incidence of breast cancer, previous observational studies have not yielded definitive results. In the Women's Health Initiative dietary trial, breast cancer incidence was not significantly different between the low-fat diet group and the control group. However, findings from previous studies in humans on the association between adolescent diet and breast cancer are inconsistent and self-reports of childhood diets may yield biased results. The DISC06 follow-up study explored the hypothesis that diet during adolescence may play a greater role in breast cancer risk than diet during adulthood by evaluating the longer-term effects of the DISC intervention during childhood and adolescence on subsequent biomarkers that have been associated with breast cancer risk in adults.Participants: In the original DISC study, 663 children 8-10 years old with elevated LDL-cholesterol were recruited into DISC at six clinical centers between 1988 and 1990. From 2006 to 2008, all female DISC participants, who were 25 to 29 years old at the time of the follow-up study, were invited to participate in the DISC06 follow-up study and 260 (86.4%) of the 301 females originally randomized in DISC participated.Design: The DISC06 follow-up study enrolled young adult women who had participated in the DISC dietary intervention during childhood and adolescence to examine biomarkers associated with adult breast cancer risk, including serum levels of estrogens and progesterone, breast density, and bone mineral density.Each participant attended a single clinic visit between 2006 and 2008. These follow-up data collection visits were timed to occur in the luteal phase of the menstrual cycle, 1-14 days before the anticipated start of next menses. Participants completed questionnaires that covered following topics: demographic characteristics, medical history, reproductive and menstrual histories, prescription and non-prescription drug use including extensive information on past and current hormone use, health habits including smoking and alcohol use, family history of breast cancer, and leisure physical activity. Data from three nonconsecutive 24-hour dietary recalls collected over 2 weeks were averaged to estimate nutrient intakes. Participants completed menstrual cycle calendars following visits for up to 6 weeks until the start of their next menses. Hormones were measured in serum that was collected in the morning after an overnight fast by venipuncture using standard procedures. Breast density was measured using non-contrast magnetic resonance imaging (MRI). Bone density was measured using clinical dual-energy x-ray absorptiometry (DXA) protocols. Conclusions: Results from the DISC06 follow-up study did not support the hypothesis that consumption of a lower fat diet during adolescence reduces breast cancer risk via effects on subsequent serum estradiol and progesterone levels, breast density or BMD.Dorgan JF, Liu L, Klifa C, Hylton N, Shepherd JA, Stanczyk FZ, Snetselaar LG, Van Horn L, Stevens VJ, Robson A, Kwiterovich PO Jr, Lasser NL, Himes JH, Pettee Gabriel K, Kriska A, Ruder EH, Fang CY, Barton BA. Adolescent diet and subsequent serum hormones, breast density, and bone mineral density in young women: results of the Dietary Intervention Study in Children follow-up study. Cancer Epidemiol Biomarkers Prev. 2010 Jun;19(6):1545-56. doi: 10.1158/1055-9965.EPI-09-1259. Epub 2010 May 25. PMID: 20501774; PMCID: PMC2883023.

Study phs004554

NCTN: Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment (AHEP0731)

Study ID: AHEP0731 NCT Number: NCT00980460Children's Oncology Group (COG) Submitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment (AHEP0731)Trial Description: This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy. Clinical data presented in the following publication(s): PMID 28211941PMID 30975630 PMID 34762296PMID 35810020PMID 37073741Disease type(s): Gastrointestinal Neoplasm - Liver and Hepatobiliary Cancer Clinical Dataset(s) included: • NCT00980460-D1 (PMID 28211941): There are three datasets (-D1 through -D3) for the AHEP0731 publication 28211941, reporting on the high-risk cohort who received Vincristine and Irinotecan. This dataset provides the information for baseline characteristics, PRETEXT grouping, surgery details, changes in AFP levels, response, relapse site, and surgical outcome plus event-free and overall survival for all evaluable patients as reported in the manuscript. Information is only provided for evaluable patients (analysiset = 1). Variables were left blank for the patients who were not evaluable (analysiset = 0). There is one row per patient. NCT00980460-D2 and -D3 contain toxicity data for this high-risk cohort. • NCT00980460-D2 (PMID 28211941): There are three datasets (-D1 through -D3) for the AHEP0731 publication 28211941, reporting on the high-risk cohort who received Vincristine and Irinotecan. This dataset provides the information for the specific toxicities that occurred during cycles 1 through 10 for evaluable patients. Evaluable patients are defined in NCT00980460-D1 (analysiset = 1). There are multiple rows per patient depending on whether they had multiple cycles submitted. NCT00980460-D1 contains baseline characteristics and outcome data and NCT00980460-D3 contains nausea and neuropathy toxicity events for this high-risk cohort. • NCT00980460-D3 (PMID 28211941): There are three datasets (-D1 through -D3) for the AHEP0731 publication 28211941, reporting on the high-risk cohort who received Vincristine and Irinotecan. This dataset provides the information for nausea and neuropathy that occurred during cycles 1 and 2 for evaluable patients. Evaluable patients are defined in NCT00980460-D1 (analysiset = 1). There is one row per patient. NCT00980460-D1 contains baseline characteristics and outcome data and NCT00980460-D2 contains toxicities from cycles 1 through 10 for this high-risk cohort. • NCT00980460-D4 (PMID 30975630): There are two datasets (-D4 and -D5) for the AHEP0731 publication 30975630, reporting on the low-risk cohort. This dataset provides the information for eligibility, baseline characteristics, disease stage, PRETEXT grouping, surgery details, changes in AFP levels, surgical outcome event-free survival, and overall survival. Information is only provided for eligible patients (analysis01 = 1). There is one row per patient. NCT00980460-D5 contains toxicity data for the low-risk cohort. • NCT00980460-D5 (PMID 30975630): There are two datasets (-D4 and -D5) for the AHEP0731 publication 30975630, reporting on the low-risk cohort. This dataset provides the information for the specific toxicities that occurred during protocol therapy. Evaluable patients are defined in NCT00980460-D4 (analysis01 = 1). There is one row per patient/toxicity term. Each row has the maximum grade of the particular toxicity term observed during the patient's protocol treatment. NCT00980460-D4 contains baseline characteristics and outcome data for the low-risk cohort. • NCT00980460-D6 (PMID 34762296): There are three datasets (-D6 through -D8) for the AHEP0731 publication 34762296, reporting on the intermediate-risk cohort. This dataset provides the information for all intermediate-risk patients who were enrolled on AHEP0731, up to 02/10/2020, both eligible and ineligible. It contains data presented in Figure 1 (the consort diagram), Figure 2 (Event-Free and Overall Survival of Patients with Unresectable non-Metastatic Hepatoblastoma), Table 1 (Patient Demographics for Patients with Intermediate-risk Hepatoblastoma), and the baseline characteristics, relapse sites, PRETEXT grouping, changes in AFP levels, surgery type, and evaluability for toxicity analyses. There is one row per patient. There are 105 patients in this dataset. NCT00980460-D7 contains mean percentage of target dose delivered data and NCT00980460-D8 contains toxicity data for the intermediate-risk cohort. • NCT00980460-D7 (PMID 34762296): There are three datasets (-D6 through -D8) for the AHEP0731 publication 34762296, reporting on the intermediate-risk cohort. This dataset, NCT00980460-D7, provides the information for all eligible intermediate-risk patients enrolled on AHEP0731, up to 02/10/2020. It contains data on the mean percentage of the target dose delivered for chemotherapy. There are 195 observations in this dataset, multiple rows per patient, with proportion of target dose delivered for cisplatin, 5-FU, doxorubicin and vincristine. NCT00980460-D6 contains baseline characteristics and outcome data and NCT00980460-D8 contains toxicity data for the intermediate-risk cohort. • NCT00980460-D8 (PMID 34762296): There are three datasets (-D6 through -D8) for the AHEP0731 publication 34762296, reporting on the intermediate-risk cohort. This dataset, NCT00980460-D8, provides the information for adverse events recorded for all eligible intermediate-risk patients enrolled on AHEP0731, up to 02/10/2020. It contains data on Table 2 (Toxicities (Grade 3, 4, and 5) of Patients with Intermediate-risk Hepatoblastoma), and the information on adverse events and toxicities in the Results section of the manuscript. There are 723 observations, one for each toxicity type per patient per cycle, included in this dataset. The number of rows per patient is dependent on the number of adverse events submitted. NCT00980460-D6 contains baseline characteristics and outcome data and NCT00980460-D7 contains mean percentage of target dose delivered data for the intermediate-risk cohort. • NCT00980460-D9 (PMID 35810020): There is one dataset for the AHEP0731 publication 35810020, reporting on the very low-risk cohort. NCT00980460-D9 provides the information for the 8 very low-risk hepatoblastoma patients who were enrolled on AHEP0731. The dataset contains baseline characteristics, α-fetoprotein levels, pretext group, vascular involvement, surgical details and tumor histology from local and central review, as well as outcome data as reported in the manuscript. It is used to generate all the tables in the manuscript, (Table 1. Patient Characteristics for Children with Very Low-Risk Hepatoblastoma and Table 2. Clinical and Surgical Traits for Children with Very Low-Risk Hepatoblastoma), and Figure 2. Event-free Survival and Overall Survival of Patients with Very Low Risk Hepatoblastoma Resected at Diagnosis. There are 8 patients in this dataset. There is one row for each patient. • NCT00980460-D10 (PMID 37073741): There are two datasets (-D10 and -D11) for the AHEP0731 publication 37073741, reporting on the high-risk cohort who received Vincristine, Irinotecan, and Temsirolimus. This dataset, NCT00980460-10, provides the information of baseline characteristics, α-fetoprotein levels, α-fetoprotein and RECIST response, as well as details on recurrent disease, metastatic disease, and surgery for the 40 high-risk hepatoblastoma patients who were enrolled on AHEP0731. Tumor histologic information and pretext classification from central review are also included as well as outcome data as reported in the manuscript. It is used to generate Table 1. Characteristics of eligible patients with high-risk hepatoblastoma treated with upfront vincristine/irinotecan/temsirolimus window therapy, Table 2. Response of patients to upfront vincristine/irinotecan/temsirolimus window therapy, Table 3. Surgical outcomes for patients treated with vincristine/irinotecan/temsirolimus upfront window therapy, Figure 1. Alpha-fetoprotein (AFP) decline after two cycles of VIT (vincristine/irinotecan/temsirolimus) therapy, and Figure 2. Event-free and overall survival of patients with high-risk hepatoblastoma treated with VIT (vincristine/irinotecan/temsirolimus). There are 40 patients in this dataset. There is one row for each patient. NCT00980460-D11 contains toxicity data for this high-risk cohort. • NCT00980460-D11 (PMID 37073741): There are two datasets (-D10 and -D11) for the AHEP0731 publication 37073741, reporting on the high-risk cohort who received Vincristine, Irinotecan, and Temsirolimus. This dataset, NCT00980460-D11, provides all grade 3 and 4 adverse events while on protocol therapy for the 36 eligible high-risk hepatoblastoma patients enrolled on AHEP0731 (Supplemental Table 3. Selected Grade 3 and 4 Toxicities) as well as selected grade 3 and 4 adverse events while on protocol therapy (Table 4. Selected grade 3 and 4 toxicities for patients treated with vincristine/irinotecan/temsirolimus upfront window therapy followed by cisplatin/5-fluorouracil/vincristine/doxorubicin.). The number of rows per patient is dependent on the number of adverse events submitted. NCT00980460-D10 contains baseline characteristics and outcome data for this high-risk cohort. You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

Study phs004135

8432 results for "canc*"

in 38.03 milliseconds.