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Familial and Atypical Urothelial Cancer Registry

This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00902590
First received: May 14, 2009
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Familial and Atypical Urothelial Cancer Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Cases will be invited to provide a saliva sample and tissue


Estimated Enrollment: 3200
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902590

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

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Dean Bajorin, MD            
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk 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 Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Dean Bajorin, MD            
Memoral Sloan Kettering Cancer Center@Phelps Recruiting
Sleepy Hollow, New York, United States
Contact: Dean Bajorin, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Dean Bajorin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00902590     History of Changes
Other Study ID Numbers: 09-025
Study First Received: May 14, 2009
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
renal pelvis
ureter
bladder
09-025
Renal Pelvis, Ureter, Bladder Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Pelvic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases
Ureteral Diseases

ClinicalTrials.gov processed this record on June 13, 2013