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NCT02400944 Clinical Trial

Determinants of Bladder Cancer Recurrence Study (The DETER Study)

Bladder Cancer Clinical Trial

Official title:
Determinants of Bladder Cancer Recurrence Study (The DETER Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02400944
Other study ID # 15-047
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2015
Est. completion date March 2025

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to learn how different lifestyle factors, such as cigarette smoking and body weight, change after a diagnosis of bladder cancer, and how they influence who gets a bladder cancer recurrence and who does not.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients =18 years old AND - Histologically-confirmed non-muscle invasive bladder cancer (NMIBC) Exclusion Criteria: - Patients are ineligible for the study if they have/had: - Histologically-confirmed NMIBC diagnosed >36 months prior to enrollment - Cystectomy prior to enrollment - Any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent or comply with study procedures - Non English-speaking

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• questionnaires
The study questionnaires (baseline and 2 follow-ups) will capture information on how modifiable factors, including the patients' smoking habits and body weight, have changed since last contact. RSA will conduct this interview at a time convenient to the patient either during a scheduled clinic visit or by telephone.
Other:
• Saliva and/or urine sample
Patients will contribute approximately 5 mL of saliva at baseline, and at the time of their follow-up questionnaires. If the patient declines to contribute a saliva specimen, they can contribute approximately 10mL of urine. Urine is routinely collected from bladder cancer patients for clinically-related tests. We will also collect urine from every participant for whom the sample is not depleted by clinical tests at the end of the day. Saliva/urine specimens will be tested for cotinine which is regarded as the gold standard to detect recent smoking exposure and is widely used to identify active smokers in epidemiologic studies.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence will be defined as the presence of pathologically-confirmed NMIBC lesion >8 weeks after diagnosis 1 year
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