Clinical trial · Observational
The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
NCT00829920CI-TRIAL-00011041completedClinicalTrials.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)
The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment. The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Bladder cancer
- description
- Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy.
Primary outcomes (1)
- measure
- Effect of therapy
- timeFrame
- baseline and then every 2 months
- description
- To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.
Secondary outcomes (3)
- measure
- Presence of baseline CTC
- timeFrame
- baseline and then every 2 months
- description
- Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of transitional cell carcinoma of the urothelium of at least T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present. * Clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy. * Participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study. * Subject must be 18 years of age or older * Subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study. * Prior therapies for bladder cancer will be allowed if patient currently has muscle-invasive or metastatic bladder cancer despite the previous treatments. * Predicted life expectancy of \> 12 weeks. Exclusion Criteria: * Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.