Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Other Indications, Bladder Cancer |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2004 |
| End Date: | July 2013 |
Pilot Study: Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer
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.
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.
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.
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.
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
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