Tuberculin specific T-cell response after intravesical BCG-instillations.
Completed
- Conditions
- BCG-itisinfection after treatment of bladder carcinoma1002844010004994
- Registration Number
- NL-OMON35614
- Lead Sponsor
- aboratorium voor Medische Microbiologie & Immunlogie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients with superficial bladder carcinoma to be treated with BCG-fluid lavages.
Dit betreft patienten met high grade urothelial cell carcinma (G3), multiple PT1 urothelial cell carcinoma, recurrent urothelial cell carcinoma despite intravesical chemotherapy, CIS and age above 18.
Exclusion Criteria
under age of 18.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Development of reliable and reproducible elispot procedure on cells obtained<br /><br>from the bladder.<br /><br>- Validation of elispot PPD on bladder lavage fluids<br /><br>- Determination of the diagnostics and predictive value of Elispot PPD for<br /><br>BCG-related complications.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Which proportion of patients undergoing BCG-installations converts from<br /><br>systemic negatieve reaction to positieve reaction<br /><br>- Correlation of systemic conversion with disease (BCG-itis)<br /><br>- Do local reactions correlate with tumoractivity and /or reduction; does the<br /><br>reaction predict the oncologic outcome ?<br /><br>- Do actual diagnostic procedures give rise to an underestimation of the number<br /><br>of BCG-itis patients and if so, can Elispot-<br /><br>PPD contribute to earlier identification of patients with BCG-ralated<br /><br>complications.<br /><br>- Does Elispot PPD have a predictive value for development BCG-therapy related<br /><br>conditions.</p><br>