Search Results - EGA European Genome-Phenome Archive

HINTS Geo-Coded Data 2014 (HINTS 4 Cycle 4)

The Health Information National Trends Survey (HINTS) is a nationally representative survey which has been administered every few years by the National Cancer Institute since 2003. HINTS 4 includes four mail-mode data collection cycles over the course of three years. Cycle 4 was conducted from August 19 through November 17, 2014. Cycle 4 was conducted by mail using a protocol similar to that used in Cycles 1, 2, and 3 with a goal of obtaining 3,500 completed questionnaires, with a final respondent sample of 3,677.

Study phs004209

NCTN: A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node (ACOSOG-Z0011)

Study ID: ACOSOG-Z0011NCT Number: NCT00003855 Alliance for Clinical Trials in OncologySubmitted in collaboration with the NCTN/NCORP Data Archive Trial Title: NCTN: A Randomized Trial of Axillary Node Dissection in Women with Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node (ACOSOG-Z0011)Trial Description: RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.Clinical data presented in the following publication(s):PMID 21304082 Disease type(s): Breast Neoplasm - Breast Neoplasm, MiscellaneousClinical dataset(s) included:NCT00003855-D1 (PMID 21304082): There is one dataset associated with the primary analysis publication (PubMed ID: 21304082) for study NCT00003855. This dataset contains baseline characteristics, treatment arm, lymph node surgery information, estrogen and progesterone receptor status, and recurrence and survival data.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 phs004234

Blood and Marrow Clinical Trials Network (BMT CTN) Comparing Peripheral Blood Stem Cell Transplantation versus Bone Marrow Transplantation in Individuals With Hematologic Cancers (0201) (BMT-CTN-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 compare survival rates of patients with hematologic cancers that received transplantation of granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells (PBSC) versus marrow from HLA-compatible unrelated donors.BackgroundMany studies of allogeneic marrow transplantation have shown that a higher dose of marrow cells correlates with a stronger hematopoietic engraftment and lower mortality from infectious complications. Peripheral blood stem cells (PBSC) collected after mobilization with granulocyte colony stimulating factor (G-CSF) contain a large number of CD34-positive progenitors and total cells than bone marrow. These observations led to the hypothesis that transplantation of PBSC would lead to lower mortality compared to transplantation of marrow. However, some studies have also shown increased risk of acute and chronic graft-versus-host disease (GVHD), as compared to bone marrow.Participants Between March 2004 and September 2009, 551 subjects were enrolled at 48 centers. Eligible subjects were less than 66 years of age and were planning to undergo transplantation for acute leukemia, myelodysplasia, chronic myeloid or myelomonocytic leukemia, or myelofibrosis. Design Subjects were randomly assigned in a 1:1 ratio to peripheral-blood stem-cell or bone marrow transplantation, stratified according to transplantation center and disease risk. Donors and recipients were DNA typed to ensure matching for 5 or 6 of the HLA-A, B, and DRB1 antigens. Peripheral-blood stem-cell donors were prescribed filgrastim or lenograstim at a dose of 10 μg per kilogram per day for 5 days and underwent apheresis. Recipients received one of four conditioning regimens and one of two GVHD prophylaxis regimens that were specified prior to randomization. Supportive care and treatment for GVHD were provided according to institutional standards. Subjects were followed in the study for 3 years. The primary end point was 2-year survival as assessed by means of an intention-to-treat analysis. Secondary end points included post-transplantation incidences of neutrophil and platelet engraftment, graft failure, acute and chronic GVHD, relapse, and infections. Conclusions There was no detected significant survival differences between peripheral-blood stem-cell and bone marrow transplantation from unrelated donors. Further analysis indicated that peripheral-blood stem cells may reduce the risk of graft failure, whereas bone marrow may reduce the risk of chronic GVHD (Anasetti, C. et al., N Engl J Med. 2012).

Study phs004601

NCTN: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma (CALGB-90601)

Study ID: CALGB-90601NCT Number: NCT00942331 Alliance for Clinical Trials in OncologySubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma (CALGB-90601)Trial Description: This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given with or without bevacizumab in treating patients with urinary tract cancer. Clinical data presented in the following publication(s):PMID 33989025 Disease type(s): Urothelial Tract Neoplasm - Urothelial Tract/Bladder CancerClinical Dataset(s) included:NCT00942331-D1 (PMID 33989025): Dataset NCT00942331-D1 is one of 3 datasets associated with PubMed ID 33989025. This dataset contains all patient level data including baseline characteristics, survival status and time to event, progression free survival and time to event, treatment summaries, off treatment reasons for chemotherapy and bev/placebo, best response, tumor scans, the occurrence of grade 3/4 thrombocytopenia, the occurrence of a serious adverse event, and the occurrence of a dose delay or reduction.NCT00942331-D2 (PMID 33989025): Dataset NCT00942331-D2 is one of 3 datasets associated with PubMed ID 33989025. This dataset contains dose modification reasons for all patients with at least one dose reduction or delay. There is also a variable distinguishing the dose modification between cisplatin and gemcitabine.NCT00942331-D3 (PMID 33989025): Dataset NCT00942331-D3 is one of 3 datasets associated with PubMed ID 33989025. This dataset contains adverse event information.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 phs004243

NCTN: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (S0819)

Study ID: S0819NCT Number: NCT00946712 SWOG Cancer Research NetworkSubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) (S0819)Trial Description: This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer. Clinical data presented in the following publication(s):PMID 29169877Disease type(s): Lung, Mediastinal and Pleural Neoplasm - Non-Small Cell Lung CancerClinical Dataset(s) included:NCT00946712-D1 (PMID 29169877): There are three datasets associated with PMID 29169877: NCT00946712-D1, -D2, and -D3. This clinical dataset, NCT00946712-D1, contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, EGFR FISH results, protocol deviations, and baseline information. It also contains response and survival data.NCT00946712-D2 (PMID 29169877): There are three datasets associated with PMID 29169877: NCT00946712-D1, -D2, and -D3. This toxicity dataset, NCT00946712-D2, contains event-level information (one row per patient per adverse event experienced on trial).NCT00946712-D3 (PMID 29169877): There are three datasets associated with PMID 29169877: NCT00946712-D1, -D2, and -D3. This dataset, NCT00946712-D3, contains specific reasons for off treatment due to toxicity.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 phs004231

NCORP: Vitamin D and Breast Cancer Biomarkers (CALGB-70806)

Study ID: CALGB-70806NCT Number: NCT01224678 Alliance for Clinical Trials in OncologySubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCORP: Vitamin D and Breast Cancer Biomarkers (CALGB-70806)Trial Description: RATIONALE: Vitamin D may help prevent breast cancer.PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients. Clinical data presented in the following publication(s):PMID 33849913 Disease type(s): Breast Neoplasm - Breast Neoplasm, MiscellaneousNon-neoplastic Disorder - Non-neoplastic Disorder, MiscellaneousClinical Dataset(s) included:NCT01224678-D1 (PMID 33849913): Dataset NCT01224678-D1 is one of 2 datasets associated with PubMed ID 33849913. This dataset contains baseline and change in breast density, baseline characteristics, change in Vitamin D levels, and off treatment reasons.NCT01224678-D2 (PMID 33849913): Dataset NCT01224678-D2 is one of 2 datasets associated with PubMed ID 33849913. This dataset contains data presented in the safety analyses.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 phs004250

NCTN: A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL) (E1912)

Study ID: E1912NCT Number: NCT02048813 ECOG-ACRIN Cancer Research GroupSubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL) (E1912)Trial Description: This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Clinical data presented in the following publication(s):PMID 31365801 PMID 34407545Disease type(s): Hematopoietic Neoplasm/Leukemia - Chronic Lymphoid LeukemiaClinical dataset(s) included:NCT02048813-D1 (PMID 31365801): There are three different datasets (-D1 through -D3) for ECOG-ACRIN trial E1912's primary publication, PMID 31365801. This dataset, NCT02048813-D1, contains baseline characteristics, stratification factors, IGHV mutation status, treatment, second primary cancer, and efficacy data. NCT02048813-D2 (PMID 31365801): There are three different datasets (-D1 through -D3) for ECOG-ACRIN trial E1912's primary publication, PMID 31365801. This dataset, NCT02048813-D2, contains grade 3 and above toxicity data as shown in Table 2 of the paper. NCT02048813-D3 (PMID 31365801): There are three different datasets (-D1 through -D3) for ECOG-ACRIN trial E1912's primary publication, PMID 31365801. This dataset NCT02048813-D3 contains worst grade, treatment-related toxicity data as shown in supplemental Table S7 of the paper. NCT02048813-D4 (PMID 34407545): There are two different datasets (-D4 and -D5) for ECOG-ACRIN trial E1912's publication, PMID 34407545, reporting on measurable residual disease and progression-free survival. This dataset, NCT02048813-D4, contains baseline characteristics, baseline leukocytes, thymidine kinase, and survival data for patients with MRD data that were not already included in NCT02048813-D1.NCT02048813-D5 (PMID 34407545): There are two different datasets (-D4 and -D5) for ECOG-ACRIN trial E1912's publication, PMID 34407545, reporting on measurable residual disease and progression-free survival. This dataset, NCT02048813-D5, contains longitudinal measurable residual disease data.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 phs004233

NCTN: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>= 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC) (E1505)

Study ID: E1505NCT Number: NCT00324805ECOG-ACRIN Cancer Research Group Submitted in collaboration with the NCTN/NCORP Data Archive Trial Title: NCTN: A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB (>= 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC) (E1505) Trial Description: This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer. Clinical data presented in the following publication(s): • PMID 29129443 Disease type(s): Lung, Mediastinal and Pleural Neoplasm - Non-Small Cell Lung Cancer Clinical dataset(s) included: • NCT00324805-D1 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D1, contains baseline characteristics, stratification factors, treatment, resection type, site of recurrence, and efficacy data. • NCT00324805-D2 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D2, contains grade 2 toxicity data presented in Table 2 of the manuscript. • NCT00324805-D3 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D3, contains grades 3-5 toxicity data presented in Table 3 of the manuscript. • NCT00324805-D4 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D4, contains worst grade toxicity information and can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement. 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 phs004246

Disentangling the Effect of Black/African Ancestry from Confounding Variables on Colorectal Cancer Biology

This study examined the effect of African ancestry on AI assisted computation of tumor infiltrating lymphocytes (TIL%) scores from hematoxylin and eosin stained whole slide images (WSI) assembled from three cohorts: 1.) African vs. European ancestry WSI downloaded from the TCGA-COAD-READ database; 2.) African vs. European ancestry WSI assembled from three US medical centers; 3.) Nigerian WSI assembled from a single Nigerian medical center. There were 33 African ancestry WSI suitable for analysis in the TCGA cohort and 48 African ancestry WSI in the independent US cohort. In addition to self-described African ancestry, the additional independent covariables were: 1.) Mismatch repair enzyme-deficient/ microsatellite instability-high vs. MMR-proficient/MSI-Low +microsatellite stable (MMR-d/MSI-H vs. MMR-p/MSI-L+MSS); 2.) Categorical age at diagnosis/resection (75 y); 3.) Sex (Male vs. Female); tumor location (Right vs. Left + Rectum); tumor stage (I+II vs. III+IV), tumor grade [G1+ G1/G2+G2 vs. G2/G3 +G3+mucinous (regardless of G)]. For the 242 TCGA cohort there were 241 parallel whole transcriptome data generated from parallel frozen tumor samples. For the independent US cohort there were 87 parallel targeted whole exome transcriptome data generated from the same formalin fixed paraffin embedded (FFPE) block. The TCGA and independent US cohort computed TIL% scores were correlated separately with CIBERSORTx derived total lymphocyte and T-cell abundance scores, and with CXCL10 and CCL5 gene expression values. mRNA gene expression count data (from STAR processing of the RNA-sequence data) and WSI for the subjects used in this study are available from the Genome Data Commons (GDC).

Study phs004622

Correlative Studies in Protocol GU16-287, which Studied Gemcitabine + (Carboplatin or Oxaliplatin) + Nivolumab in Metastatic Urothelial Cancer, which Included Collaboration with CIMAC-CIDC (Cohort 1 of 3)

Purpose: Oxaliplatin has demonstrated the ability to sensitize tumors to immune checkpoint blockade through its immunomodulatory properties in model systems of cancer. This randomized trial aimed to evaluate gemcitabine/oxaliplatin and gemcitabine/carboplatin, each combined with nivolumab, in cisplatin-ineligible metastatic urothelial carcinoma (mUC) patients. Patients and Methods: Cisplatin-ineligible patients with mUC were randomized 1:1 to gemcitabine/carboplatin plus nivolumab or gemcitabine/oxaliplatin plus nivolumab for up to 6 cycles, followed by nivolumab monotherapy. A pick-the-winner design was employed with objective response rate (ORR) as the primary endpoint. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Exploratory analyses evaluated plasma protein analytes, circulating immune cell populations, and circulating tumor cells. Results: Forty-nine patients were enrolled (carboplatin arm, N = 25; oxaliplatin arm, N = 24). The ORR was 69.6% (95% confidence interval [CI] 0.48–0.87) for the carboplatin arm and 33.3% (95% CI 0.15–0.57) for the oxaliplatin arm. Median OS was 24.74 months and 16.43 months for the carboplatin group and oxaliplatin arms, respectively (hazard ratio 1.99, 95% CI 0.94–4.22; p = 0.07). Exploratory biomarker analyses revealed sustained adaptive immune activation in the carboplatin arm and features suggestive of tumor-promoting inflammation in the oxaliplatin arm. Conclusions:Oxaliplatin-based chemo-immunotherapy, versus carboplatin-based chemo-immunotherapy, did not yield a higher response rate, challenging assumptions based on preclinical data.

Study phs004060

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