Bladder CancerNCT00848627
Screening for Bladder Cancer
An observational study of Bladder Cancer, run by Baylor College of Medicine at 3 sites in 2 countries.
Trial summary
In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will test their urine for the presence of blood daily for two 10-day testing periods with the Ames Hemastix. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Specimen and questionnaires only
- How many people
- 197 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2007to Feb 2012
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center, Baylor College of Medicine, University of Rochester Medical Center and Laval University that contain within them county hospitals, Veterans Administrations Hospitals, fee-for-service clinics, and tertiary care facilities will enroll subjects. Each site will devise their own means of soliciting participants in the study.
Who may be able to join
- Men age 60 and over, - who are current cigarette smokers OR - who have a history of at least 20 pack years smoking OR - who have over a 30 pack/year history who have stopped smoking within 10 years of the registration date OR - who have a 40 pack year history of smoking regardless of the quit date, will be eligible for participation.
- Patients with prostate or renal cancer must have been treated more than 5 years previously and be considered disease-free at the time of entry. In the case of prostate cancer, patients may have only received prostatectomy as their treatment and must have undetectable PSA's at study entry.
- In the case of calculus disease, patients must be believed to be stone free at time of study entry and could not have had a stone attack within the previous 2 years.
- Patients receiving anticoagulation therapy, such as Warfarin, Plavix, Lovenox, aspirin, etc. will be able to take part in the study and, will be thoroughly worked-up if the only explainable cause of hematuria is receiving anticoagulation medication.
Who cannot join
- history of urothelial cancer
- any malignancy other than non-melanoma skin cancers treated within the past 5 years
- benign tumors of the urinary tract that are still existent
- known urinary calculi
- medical or oncological conditions known to produce hematuria (e.g. glomerulonephritis, treatments with cyclophosphamide, methotrexate and pelvic radiation therapy)
- visual, psychological, neurological, musculoskeletal, etc. impairments that would make home testing impractical
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
M.D. Anderson Cancer Center
Houston, Texas, 77030
University of Rochester Medical Center
Rochester, New York
About this study
In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will test their urine for the presence of blood daily for two 10-day testing periods with the Ames Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue for 2 years after completion of the study.
Read the detailed description
Reduction of cancer mortality is a stated goal of the National Cancer Institute. Cancer of the bladder is the 4th most commonly diagnosed cancer and 7th leading cause of cancer death in the American men, and represents an important target for mortality-reducing efforts. Furthermore, these tumors, even in early (i.e. curable) stages, usually cause several easily detectable abnormalities, including hematuria, and the presence of abnormal tumor products that are shed into urine or lie within exfoliated malignant cells.
The overall goal of the proposed study is to gain information concerning the performance characteristics of three bladder cancer markers when combined with hematuria testing in detecting bladder cancer.
A mail back questionnaire, completed at the beginning of the study, will provide information about the participants and the results of testings will be reported after each testing period. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue or 2 years after completion of the study. At the time of the evaluation, three bladder cancer marker tests, NMP22 Bladder Chek, ImmunoCyt and UroVysion FISH will be performed, but regardless of the results, a hematuria evaluation will be completed. Data will be updated continually.
The 10 day testing with Hemastix will be repeated 9 months after the first one is completed regardless of the outcome of the first testing.
- Conditions
- Bladder Cancer
- Being tested
- Specimen and questionnaires only
- Keywords
- Bladder cancer, Smokers, Hematuria
- Medical subject headings
- Urinary Bladder Neoplasms, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen and questionnaires onlyOther
Specimen and questionnaires only
| Study group | Role | What they receive |
|---|---|---|
| Males | 60 years of age or older Smokers or history of smoking Receives: Other: Specimen and questionnaires only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Since the marker tests will only be administered to individuals with a positive Hemastix test, these are eight possible outcomes (one case with all negative marker tests and seven cases with as least one positive marker tests).
Measured: After last subject completes the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startMar 2007
- Primary completionJan 2012
- Study completionFeb 2012
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 Baylor College of MedicineThe 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
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, University of Rochester, Laval University
- Responsible party
- Principal investigator, Seth Lerner, Baylor College of Medicine
- Investigators
- Seth P. Lerner, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848627
- Sponsor's protocol ID
- H-20395
- Other IDs
- 5P50CA091846
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2009
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Bladder Cancer
- ClinicalTrials.gov ID
- NCT00848627
- Acronym / sponsor ID
- H-20395
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Smokers, Hematuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, University of Rochester, Laval University
- Study start
- Mar 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Feb 2009 (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.
In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will test their urine for the presence of blood daily for two 10-day testing periods with the Ames Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue for 2 years after completion of the study.
Detailed description
Reduction of cancer mortality is a stated goal of the National Cancer Institute. Cancer of the bladder is the 4th most commonly diagnosed cancer and 7th leading cause of cancer death in the American men, and represents an important target for mortality-reducing efforts. Furthermore, these tumors, even in early (i.e. curable) stages, usually cause several easily detectable abnormalities, including hematuria, and the presence of abnormal tumor products that are shed into urine or lie within exfoliated malignant cells.
The overall goal of the proposed study is to gain information concerning the performance characteristics of three bladder cancer markers when combined with hematuria testing in detecting bladder cancer.
A mail back questionnaire, completed at the beginning of the study, will provide information about the participants and the results of testings will be reported after each testing period. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue or 2 years after completion of the study. At the time of the evaluation, three bladder cancer marker tests, NMP22 Bladder Chek, ImmunoCyt and UroVysion FISH will be performed, but regardless of the results, a hematuria evaluation will be completed. Data will be updated continually.
The 10 day testing with Hemastix will be repeated 9 months after the first one is completed regardless of the outcome of the first testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males | – | Other: Specimen and questionnaires only60 years of age or older Smokers or history of smoking |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center, Baylor College of Medicine, University of Rochester Medical Center and Laval University that contain within them county hospitals, Veterans Administrations Hospitals, fee-for-service clinics, and tertiary care facilities will enroll subjects. Each site will devise their own means of soliciting participants in the study.
Key inclusion criteria (4 listed)
- Men age 60 and over, - who are current cigarette smokers OR - who have a history of at least 20 pack years smoking OR - who have over a 30 pack/year history who have stopped smoking within 10 years of the registration date OR - who have a 40 pack year history of smoking regardless of the quit date, will be eligible for participation.
- Patients with prostate or renal cancer must have been treated more than 5 years previously and be considered disease-free at the time of entry. In the case of prostate cancer, patients may have only received prostatectomy as their treatment and must have undetectable PSA's at study entry.
- In the case of calculus disease, patients must be believed to be stone free at time of study entry and could not have had a stone attack within the previous 2 years.
- Patients receiving anticoagulation therapy, such as Warfarin, Plavix, Lovenox, aspirin, etc. will be able to take part in the study and, will be thoroughly worked-up if the only explainable cause of hematuria is receiving anticoagulation medication.
Key exclusion criteria (6 listed)
- history of urothelial cancer
- any malignancy other than non-melanoma skin cancers treated within the past 5 years
- benign tumors of the urinary tract that are still existent
- known urinary calculi
- medical or oncological conditions known to produce hematuria (e.g. glomerulonephritis, treatments with cyclophosphamide, methotrexate and pelvic 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 and questionnaires onlySpecimen and questionnaires only | Other | Males |
Primary outcome
Since the marker tests will only be administered to individuals with a positive Hemastix test, these are eight possible outcomes (one case with all negative marker tests and seven cases with as least one positive marker tests).
Time frame: After last subject completes the 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 25 Feb 2020.
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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.
Seth P. Lerner, MD principal investigator
Baylor College of Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Baylor College of Medicine at 3 sites in 2 countries.
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 4 inclusion and 6 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Since the marker tests will only be administered to individuals with a positive Hemastix test, these are eight possible outcomes (one case with all negative marker tests and seven cases with as least one positive marker tests). (time frame: After last subject completes the 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 25 Feb 2020.