A Genotype-Phenotype Urothelial Cancer Registry

Study Overview
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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.

Official Title
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A Genotype-Phenotype Urothelial Cancer Registry

Conditions
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Urothelial Cancer, Renal Pelvis Cancer, Ureter Cancer, Bladder Cancer

Intervention / Treatment
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* Other: saliva sample and questionaire
* Other: saliva sample, questionaire


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with urothelial cancer | Other: saliva sample and questionaire<br>* 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.<br>|
| 2<br>unrelated adults accompanying patients to clinic | Other: saliva sample, questionaire<br>* Urothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal pelvis, ureter, bladder, 09-025, Renal Pelvis, Ureter, Bladder Cancer