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A Genotype-Phenotype Urothelial Cancer Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00902590
Recruitment Status : Recruiting
First Posted : May 15, 2009
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
University of Chicago
Fox Chase Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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
Urothelial Cancer Renal Pelvis Cancer Ureter Cancer Bladder Cancer Other: saliva sample and questionaire Other: saliva sample, questionaire

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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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 [ Time Frame: 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 [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Cases will be invited to provide a saliva sample and tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902590


Contacts
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Contact: Dean Bajorin, MD 646-422-4333
Contact: Helena Furberg-Barnes, PhD 646-735-8118

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Dean Bajorin, MD         
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Dean Bajorin, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dean Bajorin, MD    646-422-4333      
Contact: Helena Furberg-Barnes, PhD    646-735-8118      
Principal Investigator: Dean Bajorin, MD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Dean Bajorin, MD    646-422-4333      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Chicago
Fox Chase Cancer Center
Investigators
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Principal Investigator: Dean Bajorin, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00902590    
Other Study ID Numbers: 09-025
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
renal pelvis
ureter
bladder
09-025
Renal Pelvis, Ureter, Bladder Cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Ureteral Neoplasms
Pelvic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Ureteral Diseases