Familial and Atypical Urothelial Cancer Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
University of Chicago
Fox Chase Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00902590
First received: May 14, 2009
Last updated: October 8, 2014
Last verified: October 2014

May 14, 2009
October 8, 2014
May 2009
May 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00902590 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Familial and Atypical Urothelial Cancer Registry
Familial and Atypical Urothelial Cancer Registry

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cases will be invited to provide a saliva sample and tissue

Non-Probability Sample

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.

  • Urothelial Cancer
  • Renal Pelvis Cancer
  • Ureter Cancer
  • Bladder 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 previously completed athe "the "Urothelial Baseline Questionnaire," in an MSKCC urology clinic they will not need to complete the urothelial cancer risk questionnaire.
  • 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.
  • 1
    Patients with urothelial cancer
    Intervention: Other: saliva sample and questionaire
  • 2
    unrelated adults accompanying patients to clinic
    Intervention: Other: saliva sample, questionaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3200
May 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Dean Bajorin, MD 646-422-4333
Contact: Helena Furberg-Barnes, PhD 646-735-8118
United States
 
NCT00902590
09-025
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • University of Chicago
  • Fox Chase Cancer Center
Principal Investigator: Dean Bajorin, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP