Kidney CancerUro-DNA - GWASNCT04222374
Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC)
An observational study of Kidney Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Intervention in the UroCCR sites, Intervention in the CRB of Bordeaux University Hospital and Intervention at the Methodology and Data Management Centre of Bordeaux University Hospital
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2019to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with kidney cancer included in the UroCCR project and coming for a regular consultation visit.
Who may be able to join
- 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.
Who cannot join
- Patients below 18,
- Refusal of consent or participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Kidney Cancer
- Being tested
- Intervention in the UroCCR sites, Intervention in the CRB of Bordeaux University Hospital, Intervention at the Methodology and Data Management Centre of Bordeaux University Hospital, Subsequent intervention at the NCI (for information)
- Keywords
- Renal Cell Carcinoma, Expanded Genome-Wide Association
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention in the UroCCR sitesProcedure or surgery
- Blood sampling of a 5ml tube per patient. (for eligible patients recruited in the study, after signing the consent)
- 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.
- Transmission of the extracted DNA samples to the Biological Resource Center (CRB) of Bordeaux.
Intervention in the CRB of Bordeaux University HospitalProcedure or surgery
- Temporary storage of DNA samples for Expanded GWAS before shipping to the NCI. Storage of samples for the DNA biobank.
- Overall packing of GWAS samples for shipment to the NCI.
- 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 HospitalProcedure or surgery
Transfer of the data associated with the samples to the NCI.
Subsequent intervention at the NCI (for information)Procedure or surgery
- Samples will be genotyped at the NCI Cancer Genomics Research Lab using the Illumina Global Screening Network.
- GWAS combined meta-analysis, based, among others, on the results from the UroCCR samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Inclusion Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start10 Dec 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222374
- Sponsor's protocol ID
- CHUBX 2019/20
- Acronym
- Uro-DNA - GWAS
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC) (Uro-DNA - GWAS)
- ClinicalTrials.gov ID
- NCT04222374
- Acronym / sponsor ID
- Uro-DNA - GWAS / CHUBX 2019/20
- Conditions
- Kidney Cancer
- Keywords
- Renal Cell Carcinoma, Expanded Genome-Wide Association
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with kidney cancer included in the UroCCR project and coming for a regular consultation visit.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- Patients below 18,
- Refusal of consent or participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention in the UroCCR sites1. 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. | Procedure or surgery | – |
| Intervention in the CRB of Bordeaux University Hospital1. 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. | Procedure or surgery | – |
| Intervention at the Methodology and Data Management Centre of Bordeaux University HospitalTransfer of the data associated with the samples to the NCI. | Procedure or surgery | – |
| Subsequent intervention at the NCI (for information)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. | Procedure or surgery | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of new clear cell Renal Cell Carcinoma (ccRCC) risk loci (time frame: Inclusion Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020; AzTrials last refreshed its copy on 4 Nov 2026.