Determinants of Bladder Cancer Recurrence Study (The DETER Study)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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-
New Jersey
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Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
patients with bladder cancer
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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 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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
recurrence
Time Frame: 1 year
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will be defined as the presence of pathologically-confirmed NMIBC lesion >8 weeks after diagnosis
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1 year
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Helena Furburg-Barnes, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urologic Neoplasms
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
Other Study ID Numbers
- 15-047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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