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Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer

NCT ID: NCT00582387

Last Updated: 2015-12-18

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

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of the study is to see if we will be more able to tell what the risk is for bladder cancer to reoccur or worsen when genetics and risk factors are examined along with the stage and grade of the tumor. Superficial bladder cancer is a cancer that does not grow into the muscle layer of the bladder wall. Even though it is a superficial cancer, this type of cancer tends to come back after being treated and is often more aggressive when it returns. We already know, that the "stage" or how deeply the tumor grows into the bladder wall and the "grade" or how fast the tumor grows affect whether the tumor will come back or get worse over time. Now we use information about the stage and grade of your tumor to decide how to treat the tumor and how often you should be checked after the treatment is over. However, this has not been very reliable, because each person has unique genetic characteristics and other factors that are likely to affect what happens to the tumor over time. For instance, we know the risk for developing a cancer may be affected by your surroundings and other factors such as what you eat, the type of habits you have such as smoking, and the type of job you have, but not everyone exposed to the same risk factors gets a cancer. We believe this is due to unique genetic characteristics in each person which may help their body fight cancer.

Detailed Description

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This is a hospital based cohort study where subjects diagnosed within twelve months with nonmuscle invasive bladder cancer will be evaluated to determine whether candidate genetic variants are associated with the risk of recurrence and progression. Known tumor variables will be stratified and correlated with markers. The long term goal is to estimate the predicted risk of recurrence or progression well enough to modify surveillance schedules. Since 40% of superficial bladder cancer patients will never recur or progress, these individuals could return less frequently for followup, saving costs and discomfort. All patients will receive usual care and be followed to determine rates of recurrence and progression of the disease. Each subject will donate 30 ml of blood for extraction of genomic DNA and isolation of lymphocytes to assess DNA damage/repair function. In addition, each subject who undergoes a transurethral resection of the bladder (TURB) and/or random bladder biopsies as part of his/her usual care will donate urothelial cells from the random bladder biopsies for analyses of DNA damage/repair function. The DNA repair capacity of lymphocytes will be correlated with that of normal bladder tissue to evaluate the use of lymphocytes as a surrogate marker. When bladder biopsy tissue is not available, urothelial cells will be obtained from a cystoscopic or catheterized bladder lavage.

Conditions

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Bladder Cancer Urinary Cancer Nonmuscle Invasive Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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nonmuscle invasive bladder cancer

This is a hospital-based cohort study in which subjects with non-muscle invasive bladder cancer diagnosed within the previous 12 months will be evaluated to determine whether candidate genetic variants in patients with superficial bladder cancer can predict the risk of disease recurrence and/or progression, with the goal of modifying surveillance schedules as a function of predicted risk of recurrence or progression. All patients will be treated according to the treatment plan as outlined by their attending physician. The study will not require any deviation from the planned usual treatment.

specimen samples

Intervention Type GENETIC

blood, urine and tissue

questionnaires

Intervention Type BEHAVIORAL

Interventions

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specimen samples

blood, urine and tissue

Intervention Type GENETIC

questionnaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* They have been diagnosed with a primary nonmuscle invasive bladder cancer within the previous 12 months.
* They speak English or a language for which we have a translated consent form
* They understand and agree to sign informed consent
* They agree to donate a 30ml blood sample
* They agree to give us a bladder tissue sample as part of normal clinical procedures (three 3mm cold cup bladder biopsies or urothelial cells by bladder lavage)
* They agree to complete the study questionnaires
* They agree to have their pathology information reviewed. This could include biopsy specimens.
* All subjects must be age 21 or older

Exclusion Criteria

* Age less than 21 years
* History of other cancer diagnosis excluding nonmelanoma skin cancers
* History of muscle invasive bladder cancer
* Initial diagnosis more than 12 months from entry date into study
* History of prior intravenous chemotherapy or radiation therapy
* Bladder histology other than transitional cell cancer and its variants.
* Pregnancy
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherri Donat, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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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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04-011

Identifier Type: -

Identifier Source: org_study_id