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

NCT04222374 | Completed

• 1 other identifier: CHUBX 2019/20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Kidney Cancer

Keywords

Renal Cell Carcinoma; Expanded Genome-Wide Association

Outcome Measures

Primary Outcomes (1)

• Identification of new clear cell Renal Cell Carcinoma (ccRCC) risk loci

  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

Interventions

Intervention in the UroCCR sites PROCEDURE

1. Blood sampling of a 5ml tube per patient. (for eligible patients recruited in the study, after signing the consent) 2. DNA extraction: * For the patients of Bordeaux University Hospital, 2 aliquots will be constituted: * 1 aliquot for Expanded GWAS, containing at least 2 μg of DNA, * 1 aliquot for the UroCCR biobank. * For patients from other UroCCR centers, only 1 aliquot will be constituted: * 1 aliquot for Expanded GWAS, containing at least 2 μg of DNA. 3. Transmission of the extracted DNA samples to the Biological Resource Center (CRB) of Bordeaux.

Intervention in the CRB of Bordeaux University Hospital PROCEDURE

1. Temporary storage of DNA samples for Expanded GWAS before shipping to the NCI. Storage of samples for the DNA biobank. 2. Overall packing of GWAS samples for shipment to the NCI. 3. Shipping to the NCI: Constitutive DNA samples must be sent to the NCI by May 1, 2020 for inclusion in the Expanded GWAS study.

Intervention at the Methodology and Data Management Centre of Bordeaux University Hospital PROCEDURE

Transfer of the data associated with the samples to the NCI.

Subsequent intervention at the NCI (for information) PROCEDURE

1. Samples will be genotyped at the NCI Cancer Genomics Research Lab using the Illumina Global Screening Network. 2. GWAS combined meta-analysis, based, among others, on the results from the UroCCR samples.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients over 18,
• Confirmed cases of renal cell carcinoma (any RCC histology) of European or African origin,
• Patients included in the UroCCR study,
• Programmed or ongoing management for kidney tumor,
• Constitutional DNA available (whole blood) for selected cases,
• Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Talence, 33400, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood sample

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Methods

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 10, 2020
• Study Start: December 10, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)