A Genotype-Phenotype Urothelial Cancer Registry

Active, not recruiting

• Conditions: Renal Pelvis Cancer; Ureter Cancer; Bladder Cancer; Urothelial Cancer
• Interventions: Other: saliva sample, questionaire; Other: saliva sample and questionaire

• Registration Number: NCT00902590
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3519

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	saliva sample, questionaire	unrelated adults accompanying patients to clinic
1	saliva sample and questionaire	Patients with urothelial cancer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States