Search Results - EGA European Genome-Phenome Archive

NCTN: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation (E1900)

Study ID: E1900NCT Number: NCT00049517 ECOG-ACRIN Cancer Research GroupSubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation (E1900)Trial Description: RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia. Clinical data presented in the following publication(s): PMID 26755712 Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Myeloid LeukemiaClinical Dataset(s) included:NCT00049517-D1 (PMID 26755712): There is one dataset for E1900's primary publication, PMID 26755712. NCT00049517-D1 contains baseline characteristics, treatment arm, transplant status, response, relapse, overall survival, event-free survival, select mutation status 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 phs004393

The Vaginal Microbiome, Maternal Response, and Preterm Birth

An estimated 13 million preterm births (PTBs) occur annually worldwide, and PTB is the single most significant contributing factor to neonatal morbidity and mortality. Mechanisms underlying PTB are unknown hampering development of effective prediction and prevention strategies. PTB is linked to local and distant infections and recent data suggests that vaginal bacterial microbiome early in pregnancy is associated with subsequent PTB. Viral infections behave differently during pregnancy, with common viral infections such as varicella and influenza causing much more severe disease during pregnancy and human papillomavirus, the causative virus in cervical cancer, associated with a 2-fold increased risk for PTB. However, comprehensive assessment of vaginal viral communities during pregnancy has not been performed. Lastly, although maternal inflammation is one of the leading triggers for PTB, the precise constellation of inflammatory signals is not known. We propose that examining microbial communities or host response alone is incomplete, but that their combination will lead to refined definitions of appropriate and inappropriate microbe-maternal biology and shed new light on the old problem of PTB. Our central hypothesis is that PTB can be estimated by a combination of three criteria: vaginal bacterial communities, vaginal eukaryotic viral communities, and maternal inflammatory response. We have an interdisciplinary team assembled including perinatologists, epidemiologists, virologists, and genomics informatics experts, leveraging the unique capabilities of The McDonnell Genome Institute at Washington University in St. Louis, a well-established pregnancy bio-specimen and clinical data infrastructure, and a high-PTB burdened racially diverse patient population to test this novel hypothesis. The aims of this project are: 1) to determine the ability of bacterial and viral communities in the vagina and their dynamics over time to predict PTB, and 2) to determine the ability of the host inflammatory response in the vagina in the context of microbial communities to predict PTB. The proposed research is innovative, for the first time, comprehensively characterizing the eukaryotic vaginal virome simultaneously with vaginal bacterial communities and longitudinally capturing the maternal response to these communities. We employ an efficient study design, a well-established research infrastructure, and renowned genome sequencing expertise to test a physiologically plausible but uninvestigated paradigm that bacterial and viral communities in concert with the maternal host response can predict PTB.

Study phs003875

NCTN: Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer (E5204)

Study ID: E5204NCT Number: NCT00303628 ECOG-ACRIN Cancer Research GroupSubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation (E5204)Trial Description: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer. Clinical data presented in the following publication(s):PMID 31852811 Disease type(s): Gastrointestinal Neoplasm - Colorectal CancerClinical dataset(s) included:NCT00303628-D1 (PMID 31852811): There are five different datasets for PMID 31852811 from trial E5204. This dataset, NCT00303628-D1, contains baseline characteristics, stratification factors, surgery information, treatment, second primary cancer and efficacy data. NCT00303628-D2 (PMID 31852811): There are five different datasets for PMID 31852811 from trial E5204. This dataset, NCT00303628-D2, contains toxicity data. NCT00303628-D3 (PMID 31852811): There are five different datasets for PMID 31852811 from trial E5204. This dataset, NCT00303628-D3, contains PRO Bowel function/uniscale data. NCT00303628-D4 (PMID 31852811): There are five different datasets for PMID 31852811 from trial E5204. This dataset, NCT00303628-D4, contains PRO FACT-Diarrhea Data. NCT00303628-D5 (PMID 31852811): There are five different datasets for PMID 31852811 from trial E5204. This dataset, NCT00303628-D5, contains PRO FACT/GOG-Ntx 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 phs004621

Urine Cell-Free RNA Analysis for Cancer Detection and Therapy Response Prediction

The goal of this study was to develop a urine cell-free RNA (cfRNA) liquid biopsy assay for bladder cancer. We developed a method called uRARE-seq, which involves targeted RNA sequencing of urine cfRNA, and applied it to urine samples from bladder cancer patients and non-cancer controls. We evaluated its performance for bladder cancer detection and monitoring. We also developed a pre-treatment urine biomarker to predict the likelihood of response to intravesical therapy.

Study phs004116

Evaluation of the Effects of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer

To characterize the advanced and metastatic breast tumor immune landscape and the impact of CDK4/6 inhibition on its composition and function, we used scRNA-seq to analyze tumor biopsies pre- and post- treatment with ET and the CDK4/6i, abemaciclib. Patients with ER+/HER2- advanced or metastatic breast cancer starting first- or second-line CDK4/6i with ET were enrolled in the “Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2-Breast Cancer” (NCT04352777) trial. For each patient, the same lesion was biopsied prior to treatment (T1 = baseline, pretreatment) and following four weeks of continuous abemaciclib and ET (T2 = 4 weeks post-treatment). A total of 26 pre- and post-treatment tumor biopsies from diverse sites (recurrent breast and bone, liver, and lymph node metastases) from 13 patients who had varying responses to treatment were analyzed. Following tissue dissociation, positive selection of CD45+ cells was used to enrich for tumor-infiltrating immune cells. We find that genes associated with interferon response are downregulated in T cell populations and genes associated with antigen presentation were upregulated in macrophages and dendritic cells following treatment. Raw single-cell sequencing data from the 10 patients that consented to data sharing will be made available through dbGaP.

Study phs004470

NCTN: A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children with Relapsed Acute Myeloid Leukemia (AML) (AAML1421)

Study ID: AAML1421NCT Number: NCT02642965 Children's Oncology Group (COG)Submitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children with Relapsed Acute Myeloid Leukemia (AML) (AAML1421)Trial Description: This phase I/II trial studies the side effects and best dose of liposome-encapsulated daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and to see how well they work in treating younger patients with acute myeloid leukemia that has come back after treatment (relapsed) or is not responding to treatment (is refractory). Liposome-encapsulated daunorubicin-cytarabine is made up of two chemotherapy drugs, cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and cytarabine, 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. Filgrastim may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving liposome-encapsulated daunorubicin-cytarabine followed by fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common effect of other chemotherapy treatments for acute myeloid leukemia. Clinical data presented in the following publication(s): PMID 32401633 Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Myeloid LeukemiaClinical Dataset(s) included: NCT02642965-D1 (PMID 32401633): There is 1 dataset for AAML1421's primary publication, PMID 32401633. The NCT02642965-D1 dataset is a patient level dataset (single row per patient) containing patient characteristics, cytogenetic categories, tumor response, survival, neutrophil count recovery, toxicity, residual disease status, and pharmacokinetic data for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML1421 clinical trial.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 phs004160

Human GPR15 Deficiency Reveals CD8+ T Regulatory Cell-Macrophage Crosstalk in Intestinal Inflammation

Inflammatory bowel disease (IBD) causes lifelong suffering from gastrointestinal inflammation and dysfunction with severe complications including colon cancer. The disease is increasing in global prevalence, and current therapies are insufficient, highlighting an urgent need to understand its pathogenic mechanism. We reported multiple patients with GPR15 deficiency which result in severe early-onset IBD. GPR15, a G protein-coupled receptor (GPCR), expressed in immune cells and previously described as an entry co-factor for human and simian immunodeficiency viruses, is a crucial marker and homing receptor for a unique subset of intramucosal GPR15-guided regulatory CD8+ T lymphocytes (CD8+ TIGR). These cells potently kill macrophages that become aggressively activated in response to intestinal damage or disease. Thus, our identification of CD8+ TIGR cells yields new insights into organ-specific immune regulation and potential treatment strategies for IBD.

Study phs003950

Transcriptional Profiling of a Dana-Farber Cancer Institute Early-Onset Colorectal Cancer Cohort

We generated bulk RNA-seq data from 83 early-onset colorectal cancer primary tumors. Tumor samples were obtained from patients seen at the Dana-Farber Cancer Institute's Gastrointestinal Cancer Center with an age of diagnosis less than 50 years.

Study phs004807

NCTN: A Phase III Randomized Trial for Patients with De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD (AAML1031)

Study ID: AAML1031NCT Number: NCT01371981 Children's Oncology Group (COG)Submitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: A Phase III Randomized Trial for Patients with De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD (AAML1031)Trial Description: This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia. Clinical data presented in the following publication(s): PMID 32029509Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Myeloid LeukemiaClinical Dataset(s) included:NCT01371981-D4 (PMID 32029509): There is one dataset (-D4) for AAML1031's primary publication (PMID 32029509). This dataset is a patient level dataset which contains patient characteristics, consort diagram classifications, abnormal karyotype, CEBP alpha status, NPM status, minimal residual disease, survival, treatment-related mortality, and toxicity data presented in the manuscript for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML1031 clinical trial.Forthcoming Dataset(s): NCT01371981-D1, NCT01371981-D2, NCT01371981-D3, NCT01371981-D5, NCT01371981-D6You 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 phs004142

NCTN: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor (AREN0532)

Study ID: AREN0532NCT Numbers: NCT00352534Children's Oncology GroupSubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Title: NCTN: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor (AREN0532)Trial Description: This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.Clinical data presented in the following publication(s):PMID 27811504PMID 29211618Disease type(s): Kidney Neoplasm - Wilms TumorClinical Dataset(s) included:NCT00352534-D1 (PMID 27811504): There is one dataset (-D1) for the AREN0532 primary publication 27811504, reporting on the trial's very low-risk cohort. This dataset contains baseline characteristics, WT1 mutation status, loss of heterozygosity, relapse sites, presence of intralobar and perilobar rests, survival, secondary malignancy, and radiotherapy type data.NCT00352534-D2 (PMID 29211618): There are two datasets (-D2 and -D3) for the AREN0532 primary publication 29211618, reporting on patients with stage III favorable-histology Wilms tumor. There is one row for each patient enrolled. The dataset contains the data for the consort flow of patient enrollment, baseline characteristics, surgery details, 1p/16q loss of heterozygosity status, second malignant neoplasm, survival, relapse site, grade of adverse events, and tumor status data for the patients on AREN0532 as reported in the manuscript.NCT00352534-D3 (PMID 29211618): There are two datasets (-D2 and -D3) for the AREN0532 primary publication 29211618, reporting on patients with stage III favorable-histology Wilms tumor. This dataset contains EFS and OS data for patients enrolled on the Q9401 study described in the manuscript to compare outcomes for patients on AREN0532 to similar patients on Q9401 who received the same therapy.Select data from Q9401 (NCT00002611) used in AREN0532 publication PMID 29211618 are contained in NCT003525234-D3.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 phs004139

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