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Determinants of Bladder Cancer Recurrence Study (The DETER Study)

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ClinicalTrials.gov Identifier: NCT02400944
Recruitment Status : Active, not recruiting
First Posted : March 27, 2015
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Bladder Cancer Behavioral: questionnaires Other: Saliva and/or urine sample

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Bladder Cancer Recurrence Study (The DETER Study)
Study Start Date : March 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort Intervention/treatment
patients with bladder cancer 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.




Primary Outcome Measures :
  1. recurrence [ Time Frame: 1 year ]
    will be defined as the presence of pathologically-confirmed NMIBC lesion >8 weeks after diagnosis


Biospecimen Retention:   Samples With DNA
Saliva and/or urine sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSKCC clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400944


Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
American Cancer Society, Inc.
Investigators
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Principal Investigator: Helena Furburg-Barnes, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02400944    
Other Study ID Numbers: 15-047
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
MSK Tobacco Cessation Program
smoking exposure
15-047
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes