A Genotype-Phenotype Urothelial Cancer Registry

NCT ID: NCT00902590

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3519 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2026-05-31

Brief Summary

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This study is being done to create a registry to help us learn more about urinary and other cancers. This will let us look at large groups of people who do and do not have this kind of cancer.

The investigators will look at risk factors to learn more about how these impact cancer. The investigators will also look at genetic markers. These are genes that are found in a known place. They are often associated with a particular trait. If the gene changes in some way, it may predict cancer or response to treatment. The investigators will look for markers in your saliva.

This registry will help us develop better methods of:

Preventing these cancers. Diagnosing these cancers. Treating these cancers.

Detailed Description

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Conditions

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Urothelial Cancer Renal Pelvis Cancer Ureter Cancer Bladder Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with urothelial cancer

saliva sample and questionaire

Intervention Type OTHER

Urothelial Cancer Registry- Patients will complete a family history and urothelial cancer risk questionnaire, and will provide a buccal sample for germline DNA. If the cases have undergone germline sequencing as part of Protocol 12-245, they will not need to provide a buccal sample. If the cases have previously completed athe "the "Urothelial Baseline Questionnaire," in an MSKCC urology clinic they will not need to complete the urothelial cancer risk questionnaire.

2

unrelated adults accompanying patients to clinic

saliva sample, questionaire

Intervention Type OTHER

Urothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction.

Interventions

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saliva sample and questionaire

Urothelial Cancer Registry- Patients will complete a family history and urothelial cancer risk questionnaire, and will provide a buccal sample for germline DNA. If the cases have undergone germline sequencing as part of Protocol 12-245, they will not need to provide a buccal sample. If the cases have previously completed athe "the "Urothelial Baseline Questionnaire," in an MSKCC urology clinic they will not need to complete the urothelial cancer risk questionnaire.

Intervention Type OTHER

saliva sample, questionaire

Urothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Urothelial Cancer Cases

* Must be ≥ 18 years of age AND
* Must have a diagnosis of urothelial cancer AND
* Must be an English-speaker

Non-Cancer Control Group

* Must be ≥ 18 years of age AND
* Must not have cancer or a personal history of cancer, with the exception of skin cancer. AND
* Must not be a blood relative of cases AND
* Must not be a blood relative of another control AND
* Must be an English-speaker

Family Member Control Group:

In select kindreds with a high prevalence of bladder cancer and/or very early onset bladder cancer, first- and second-degree family members of probands may be contacted by the MSKCC study team and invited to complete the questionnaire and submit a saliva sample.

* Must be ≥ 18 years of age AND
* Must be a blood relative of a case participant AND
* Must be an English-speaker

Exclusion Criteria

* Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iyer Gopakumar, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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09-025

Identifier Type: -

Identifier Source: org_study_id

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