Determinants of Bladder Cancer Recurrence Study (The DETER Study)

NCT ID: NCT02400944

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with bladder cancer

questionnaires

Intervention Type BEHAVIORAL

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.

Saliva and/or urine sample

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helena Furburg-Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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15-047

Identifier Type: -

Identifier Source: org_study_id

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