NCT02400944

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 2, 2025

Status Verified

April 1, 2025

Enrollment Period

11 years

First QC Date

March 6, 2015

Last Update Submit

April 1, 2025

Conditions

Keywords

MSK Tobacco Cessation Programsmoking exposure15-047

Outcome Measures

Primary Outcomes (1)

  • recurrence

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

    1 year

Study Arms (1)

patients with bladder cancer

Behavioral: questionnairesOther: Saliva and/or urine sample

Interventions

questionnairesBEHAVIORAL

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.

patients with bladder cancer

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.

patients with bladder cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSKCC clinic

You may qualify if:

  • Patients ≥18 years old AND
  • Histologically-confirmed non-muscle invasive bladder cancer (NMIBC)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and/or urine sample

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Helena Furburg-Barnes, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 27, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 2, 2025

Record last verified: 2025-04

Locations