A Genotype-Phenotype Urothelial Cancer Registry
1 other identifier
observational
3,519
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
September 5, 2025
August 1, 2025
17.1 years
May 14, 2009
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine whether single nucleotide polymorphisms in regions discovered from whole genome scans, such as 8q24 & chromosome 3, & candidate genes, include NAT2 & GSTM1, prev found to be assoc with bladder ca risk, are assoc with UC in this study population
2 years
Secondary Outcomes (1)
To determine whether single nucleotide polymorphisms in the genes and regions listed above are associated with outcomes after UC diagnosis in the population
2 years
Study Arms (2)
1
Patients with urothelial cancer
2
unrelated adults accompanying patients to clinic
Interventions
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.
Urothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction.
Eligibility Criteria
A member of the patient's treatment team, the protocol investigator, or a member of the research team at Memorial Sloan-Kettering Cancer Center (MSKCC) will identify potential research subjects. At MSKCC the following outpatient clinics will be used to recruit UC cases: Urology and Genitourinary Oncology. Patients and families may also be directly referred to the study team by any MSKCC physician, external physician, or by the family itself.
You may qualify if:
- 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
You may not qualify if:
- Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- University of Chicagocollaborator
- Fox Chase Cancer Centercollaborator
Study Sites (4)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
Biospecimen
Cases will be invited to provide a saliva sample and tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iyer Gopakumar, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 15, 2009
Study Start
May 1, 2009
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
September 5, 2025
Record last verified: 2025-08