Tuberculin specific T-cell response after intravesical BCG-instillations.

Tuberculin specific T-cell response after intravesical BCG-instillations. - Tuberculin specific T-cell response after BCG-instillations.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35614

Enrollment

100

Registered

2010-03-11

Start date

2010-02-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BCG-itis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: under age of 18.

Design outcomes

Primary

Measure	Time frame
- Development of reliable and reproducible elispot procedure on cells obtained from the bladder. - Validation of elispot PPD on bladder lavage fluids - Determination of the diagnostics and predictive value of Elispot PPD for BCG-related complications.	—

Secondary

Measure	Time frame
- Which proportion of patients undergoing BCG-installations converts from systemic negatieve reaction to positieve reaction - Correlation of systemic conversion with disease (BCG-itis) - Do local reactions correlate with tumoractivity and /or reduction; does the reaction predict the oncologic outcome ? - Do actual diagnostic procedures give rise to an underestimation of the number of BCG-itis patients and if so, can Elispot- PPD contribute to earlier identification of patients with BCG-ralated complications. - Does Elispot PPD have a predictive value for development BCG-therapy related conditions.	—

Measure

Time frame

- Which proportion of patients undergoing BCG-installations converts from systemic negatieve reaction to positieve reaction - Correlation of systemic conversion with disease (BCG-itis) - Do local reactions correlate with tumoractivity and /or reduction; does the reaction predict the oncologic outcome ? - Do actual diagnostic procedures give rise to an underestimation of the number of BCG-itis patients and if so, can Elispot- PPD contribute to earlier identification of patients with BCG-ralated complications. - Does Elispot PPD have a predictive value for development BCG-therapy related conditions.

—

Countries

Netherlands

Outcome results