A Genotype-Phenotype Urothelial Cancer Registry

Bladder Cancer Clinical Trial

Official title:

A Genotype-Phenotype Urothelial Cancer Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00902590
• Other study ID #: 09-025
• Status: Recruiting
• Start date: May 2009
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Dean Bajorin, MD
• Phone: 646-422-4333
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Pelvic Neoplasms
• Renal Pelvis Cancer
• Ureter Cancer
• Ureteral Neoplasms
• Urinary Bladder Neoplasms
• Urothelial Cancer

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Fox Chase Cancer Center, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Memorial Sloan Kettering Cancer Center