Clinical trial NCT00902590: A Genotype-Phenotype Urothelial Cancer Registry
Official title: A Genotype-Phenotype Urothelial Cancer Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Urothelial Cancer
Renal Pelvis Cancer
Ureter Cancer
Bladder Cancer
Keywords: renal pelvis
ureter
bladder
09-025
Renal Pelvis, Ureter, Bladder Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Fox Chase Cancer Center
First posted: 2009-05-15
Enrollment: 3519
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
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
timeFrame: 2 years
Secondary outcomes:
measure: To determine whether single nucleotide polymorphisms in the genes and regions listed above are associated with outcomes after UC diagnosis in the population
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dean Bajorin, MD
role: PRINCIPAL_INVESTIGATOR
References: