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Active, Not Recruiting

NCT Number: NCT02400944

Determinants of Bladder Cancer Recurrence Study (The DETER Study)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

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

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.

Primary outcomes

  1. recurrence

    Time frame: 1 year

    will be defined as the presence of pathologically-confirmed NMIBC lesion >8 weeks after diagnosis

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2015
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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