Bladder CancerNCT00582387
Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer
An observational study of Bladder Cancer and Urinary Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bladder Cancer, Urinary Cancer, Nonmuscle Invasive Bladder Cancer
- What is being tested?
- specimen samples and questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urology clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- specimen samples, questionnaires
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specimen samplesGenetic
blood, urine and tissue
questionnairesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: specimen samples; Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate genetic variants (in the DNA repair genes, cell cycle genes, and detoxifying genes) and their association with recurrence and progression in early stage bladder cancer.
Measured: conclusion of study
Secondary outcomes (1)
Compare the DNA damage/repair capacity with the genetic variants.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startMar 2004
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherri Donat, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582387
- Sponsor's protocol ID
- 04-011
- Status last verified
- Dec 2015
- First submitted
- 19 Dec 2007
- Last updated
- 18 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT00582387
- Acronym / sponsor ID
- 04-011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nonmuscle invasive bladder cancer | – | Genetic: specimen samples, Behavioral: questionnairesThis 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urology clinic
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specimen samplesblood, urine and tissue | Genetic | nonmuscle invasive bladder cancer |
| questionnaires | Behavioural | nonmuscle invasive bladder cancer |
Primary outcome
Evaluate genetic variants (in the DNA repair genes, cell cycle genes, and detoxifying genes) and their association with recurrence and progression in early stage bladder cancer.
Time frame: conclusion of study
1 secondary outcome
Compare the DNA damage/repair capacity with the genetic variants.
Time frame: conclusion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherri Donat, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Urinary Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate genetic variants (in the DNA repair genes, cell cycle genes, and detoxifying genes) and their association with recurrence and progression in early stage bladder cancer. (time frame: conclusion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.