Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC) (Uro-DNA - GWAS)

July 10, 2020 updated by: University Hospital, Bordeaux

Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC) (Uro-DNA - GWAS)

In the last decade, investigators from the Department of Cancer Epidemiology and Genetics (National Cancer Institute, USA) have conducted genome-wide association (GWAS) studies of renal cell carcinoma.

Dr. Mark PURDUE and Dr. Stephen CAHNOCK (Department of Epidemiology of Cancer and Genetics, NCI) propose to expand their genome-wide association study (Expanded GWAS) by genotyping approximately 10,000 additional cases of kidney cancer patients, in collaboration with US institutions, South-American and European.

This study describes the participation of the French Kidney Cancer Research Network (UroCCR) in the Expanded GWAS research, under the coordination of Professor BERNHARD (Bordeaux University Hospital).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the Expanded GWAS study is to better understand the role of common genetic variants in susceptibility to renal cell carcinoma (RCC).

The participation of the French UroCCR network consists in completing the bio-collection of the UroCCR cohort by preserving constitutional DNA and to provide DNA samples to the US NCI team.

This will increase the number of samples for meta-analysis and contribute to better identify clear cell kidney cancer susceptibility loci.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Talence, France, 33400
        • Centre Hospitalier Universitaire de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with kidney cancer included in the UroCCR project and coming for a regular consultation visit.

Description

Inclusion Criteria:

  • Patients over 18,
  • Confirmed cases of renal cell carcinoma (any RCC histology) of European or African origin,
  • Patients included in the UroCCR study,
  • Free, informed, written and signed consent by the participant and the investigator (at the latest on the day of inclusion and before any investigation required by the research) for specific blood collection for the purpose of DNA extraction,
  • Programmed or ongoing management for kidney tumor,
  • Constitutional DNA available (whole blood) for selected cases,
  • Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

  • Patients below 18,
  • Refusal of consent or participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of new clear cell Renal Cell Carcinoma (ccRCC) risk loci
Time Frame: Inclusion Visit

From the DNA sample collected at inclusion visit, and the derived Single Nucleotide Polymorphisms (SNPs) genotype data:

Association between evaluated genetic variants (SNPs) and renal cell carcinoma will be statistically determined if the p-value is found to be close to or lower than the Genome-wide significance threshold (p <5*10-8).
Inclusion Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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