A Genotype-Phenotype Urothelial Cancer Registry

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT00902590
Collaborator
University of Chicago (Other), Fox Chase Cancer Center (Other)
3,200
4
169
800
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: saliva sample and questionaire
  • Other: saliva sample, questionaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
3200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Genotype-Phenotype Urothelial Cancer Registry
Study Start Date :
May 1, 2009
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
1

Patients with urothelial cancer

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.

2

unrelated adults accompanying patients to clinic

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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
2 Memorial Sloan Kettering Commack Commack New York United States 11725
3 Memorial Sloan Kettering Cancer Center New York New York United States 10065
4 Memorial Sloan Kettering Nassau Uniondale New York United States 11553

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • University of Chicago
  • Fox Chase Cancer Center

Investigators

  • Principal Investigator: Dean Bajorin, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00902590
Other Study ID Numbers:
  • 09-025
First Posted:
May 15, 2009
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022