Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers

Bladder Cancer Clinical Trial

Official title:

Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723121
• Other study ID #: AE20121
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage. Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.

Description:

Background: Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage. Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 1, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with primary or recurrent NMIBC for whom primary TURBT was done.

Exclusion Criteria:

1. Patients with previous BCG instillation,

2. benign pathology

3. Variant histology

4. Non urothelial carcinoma,

5. concommitent upper tract urothelial tumors, detrusor muscle invasion

6. low or intermediate risk NMIBC

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• Urine ELISA for immunological markers (IL-2 and IL-10)
IL-2 and IL-10 levels were measured in the supernatants. Natural human-produced IL-2 and IL-10 concen¬trations were determined in the urine of all patients and controls by solid phase ELISA Quantikine IL-2 Immunoassay and IL-10 Immunoassay, respectively
• Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis
blood samples using QIAamp® RNA Blood Mini kit (QIAGEN, USA). 1 µg of total RNA was reverse transcribed with random primers, using High Capacity cDNA Archive Kit (Applied Biosystems, Foster City, CA, USA). RT-qPCR analysis was carried out with SYBER Green PCR Master Mix (Applied Biosystems, Foster City, CA, USA). Primers for TNF-a, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial BCG complete response	free cystoscopy/negative cytology at 3 months.	3 months
Primary	Recurrence	Recurrence is defined as development of new tumor/positive cytology in patients with ICR	1 year
Primary	Progression	persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response	1 year