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dbGaP phs000346 Cancer Genetic Markers of Susceptibility for Bladder Cancer (CGEMS Bladder) - pht002184.v2.p2

- 12-10-22 - 5 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: pht002184
Principal Investigator: Nathaniel Rothman, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department Health and Human Services, Bethesda, MD, USA MeSH: Urinary Bladder Neoplasms,Carcinoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000346 This study funded by the National Cancer Institute (NCI) involves conducting a genome-wide association study of common genetic variants to identify markers of susceptibility to bladder cancer. This bladder GWAS has led to the discovery of three novel regions in the genome associated with bladder cancer risk. Cases were defined as individuals having histologically confirmed primary carcinoma of the urinary bladder, including carcinoma in situ (ICD-0-2 topography codes C67.0-C67.9 or ICD9 codes 188.1-188.9). Scan data were obtained from two case-control studies carried out in Spain and the United States (specifically, those in the Maine and Vermont components of the New England Bladder Cancer Study) and three prospective cohort studies in Finland and the United States (specifically Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study, Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, and The American Cancer Society Cancer Prevention Study II Nutrition Cohort). We used data from 591,637 single nucleotide polymorphisms 3,532 affected individuals (cases) and 5,119 controls of European descent and replication including 8382 cases and 48275 controls from 16 studies. In a combined analysis, we identified three new regions associated with bladder cancer on chromosomes 22q13.1, 19q12 and 2q37.1: rs1014971, (P ≈ 8 x 10sup-12/sup) maps to a non-genic region of chromosome 22q13.1, rs8102137 (P = 2 x 10sup-11/sup) on maps to CCNE1 and rs11892031 (P = 1 x 10sup-7/sup) maps to the UGT1A cluster on 2q37.1. We confirmed four previously identified genome-wide associations on chromosomes 3q28, 4p16.3, 8q24.21 and 8q24.3 (Rothman N et al., Nature Genetics, 2010, PMID: 20972438). Through meta-analysis with the MD Anderson Texas Bladder Cancer Study (TXBCS), we also identified a novel susceptibility locus that mapped to a region of 18q12.3, marked by rs7238033 (P = 8.7 x 10(-9); allelic odds ratio 1.20 with 95% CI: 1.13-1.28) and two highly correlated SNPs, rs10775480/rs10853535 (r(2)= 1.00; P = 8.9 x 10(-9); allelic odds ratio 1.16 with 95% CI: 1.10-1.22) (Garcia-Closas M et al, Human Molecular Genetics, 2011) For NCI-GWAS2, we performed genotyping on cases and controls for the New Hampshire component of the New England Bladder Cancer Study (NEBCS-NH). For the majority of new bladder cancer cases, we genotyped only cases from four case-control studies, the Los Angeles Bladder Cancer Study (LABCS), the French Center for Research on Prostate Diseases (CeRePP), the French Bladder Study (FBCS) and the Brescia Bladder Cancer Study (BBCS). We used existing control data from four cohort studies already genotyped and subjected to rigorous quality control metrics: the European Prospective Investigation Into Cancer and Nutrition Study (EPIC), Womens Health Initiative (WHI), Health Professionals Follow-up Study (HPFS), Nurses Health Study (NHS), which have been a part of Cancer Genetic Markers of Susceptibility (CGEMS). Meta-analysis of NCI-GWAS1, NCI-GWAS2 and a previously reported GWAS TXBCS-GWAS along with taqman replication, identified two new loci: rs10936599 on 3q26.2 (P = 4.53 x 10(-9)) and rs907611 on 11p15.5 (P = 4.11 x 10(-8)). Two notable loci were also identified that approached genome-wide statistical significance: rs6104690 on 20p12.2 (P = 7.13 x 10(-7)) and rs4510656 on 6p22.3 (P = 6.98 X 10(-7)); these require further studies for confirmation (Figueroa J et al, Human Molecular Genetics, 2013).

pht002185.v2.p2

1 Itemgroep 4 Data-elementen

pht004007.v1.p2

1 Itemgroep 4 Data-elementen

Eligibility

1 Itemgroep 1 Data-element

pht002183.v2.p2

1 Itemgroep 3 Data-elementen

Eligibility Cancer Survivor NCT02077218

- 16-02-19 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Computed Tomography and Biomarker Analysis in Diagnosing Coronary Artery Disease in Asymptomatic Patients Who Have Undergone Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT02077218

dbGaP phs000855 Resistance studies in Lung Cancer - pht004553.v1.p1

- 16-03-24 - 5 Formulieren, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: pht004553
Principal Investigator: Levi A. Garraway, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts and Broad Institute of Harvard and MIT, Cambridge, Massachusetts, USA MeSH: Carcinoma,Carcinoma, Non-Small-Cell Lung https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000855 The purpose of the study was to compare gene expression profiles from a cohort of crizotinib-resistant ALK-rearranged lung tumors and a cohort of treatment-naive ALK-rearranged lung tumors. Expression profiles were generated by RNA-seq. In parallel, gene expression profiles were obtained from ALK-rearranged lung cancer cell lines in the presence or absence of the ALK inhibitor TAE684. Gene expression profiles were also obtained from ALK-rearranged cells ectopically expressing genes associated with ALK inhibitor resistance that were identified from a functional genetic study.

pht004554.v1.p1

1 Itemgroep 3 Data-elementen

pht004552.v1.p1

1 Itemgroep 3 Data-elementen

Eligibility

1 Itemgroep 1 Data-element

pht004551.v1.p1

1 Itemgroep 2 Data-elementen

dbGaP phs000628 Characterization of a Metastatic Cervical Cancer Using NGS - pht003504.v1.p1

- 29-11-22 - 4 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: pht003504
Principal Investigator: Winnie S. Liang, PhD, Translational Genomics Research Institute, Phoenix, AZ, USA MeSH: Uterine Cervical Neoplasms,Carcinoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000628 In this study, we used shallow whole genome, exome, and RNA sequencing to genomically and transcriptomically characterize a cervical squamous carcinoma lesion metastatic to the lung and to detect and analyze HPV infection in the same sample.

pht003505.v1.p1

1 Itemgroep 3 Data-elementen

pht003506.v1.p1

1 Itemgroep 4 Data-elementen

pht003507.v1.p1

1 Itemgroep 6 Data-elementen

Eligibility Disease Burden of Pathients with Incurable Cancer Disease DRKS00007536 NCT02751723 DRKS00007536 - Eligibility Disease Burden of Pathients with Incurable Cancer Disease NCT02751723 DRKS00007536

- 22-06-17 - 1 Formulier, 2 Itemgroepen, 6 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Responsible Party: Florian Lordick, MD, Prof. Dr. med. (MD, PhD), University of Leipzig ClinicalTrials.gov Identifier: NCT02751723 History of Changes Other Study ID Numbers: APM Project DRKS00007536 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: April 14, 2016 Last Updated: May 6, 2017 Individual Participant Data Plan to Share IPD: No Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease (APM-Project) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02751723

Eligibility Hepatocellular Carcinoma NCT02149771

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Combination Treatment for Advanced Liver Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02149771

Eligibility Renal Cell Carcinoma NCT00026663

- 10-02-16 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Criteria, Exclusion Criteria
Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance; ODM derived from: https://clinicaltrials.gov/show/NCT00026663

dbGaP phs000550 Characterization of Pancreatic Adenocarcinoma Patients Using NGS - pht003129.v1.p1

- 04-11-22 - 5 Formulieren, 1 Itemgroep, 5 Data-elementen, 1 Taal
Itemgroep: pht003129
Principal Investigator: Winnie S. Liang, PhD, Translational Genomics Research Institute, Phoenix, AZ, USA MeSH: Pancreatic Neoplasms,Carcinoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000550 In this study, we whole genome sequenced tumor/normal pairs from three pancreatic adenocarcinoma patients to separately characterize each patient with respect to somatic alterations. For 2 patients for whom tumor RNA was available, we also performed RNA sequencing to evaluate gene expression changes. While additional sequencing is needed to improve our understanding of the disease, the information acquired from this study contributes to our knowledge base on pancreatic cancer and helps to establish a foundation for identifying and developing more efficacious treatments for patients.

pht003130.v1.p1

1 Itemgroep 8 Data-elementen

Eligibility

1 Itemgroep 1 Data-element

pht003127.v1.p1

1 Itemgroep 3 Data-elementen

pht003128.v1.p1

1 Itemgroep 3 Data-elementen

Eligibility Nasopharyngeal Carcinoma NCT01612286

- 27-03-20 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01612286

Eligibility Stage IV Nasopharyngeal Carcinoma NCT01655628

- 15-09-21 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01655628

dbGaP phs000657 NGS in Advanced Cancers - pht003492.v1.p1

- 24-01-23 - 4 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: pht003492
Principal Investigator: Glen Weiss, MD, Translational Genomics Research Institute, Phoenix, AZ, USA MeSH: Carcinoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000657 In this study, we used NGS to identify somatic events in advanced stage cancer patients to demonstrate the feasibility for using this approach to improve patient treatment.

pht003493.v1.p1

1 Itemgroep 3 Data-elementen

pht003494.v1.p1

1 Itemgroep 4 Data-elementen

pht003495.v1.p1

1 Itemgroep 7 Data-elementen

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Initial On Study Form

- 14-03-19 - 1 Formulier, 5 Itemgroepen, 47 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Tracking Informaion, Demographic Information, Disease Information, Cancer Therapy
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

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