Clinical trial · Observational
Screening for Bladder Cancer
NCT00848627CI-TRIAL-00043619completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Specimen and questionnaires only | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Males
- description
- 60 years of age or older Smokers or history of smoking
- interventionNames
- Other: Specimen and questionnaires only
Primary outcomes (1)
- 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).
- timeFrame
- After last subject completes the study.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.