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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

Primary Purpose

Bladder Cancer

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Urine ELISA for immunological markers (IL-2 and IL-10)

Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Bladder cancer, Bacillus Calmette-Guérin response, Prediction, Urinary cytokines, T cells, Recurrence, Progression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients with previous BCG instillation,
benign pathology
Variant histology
Non urothelial carcinoma,
concommitent upper tract urothelial tumors, detrusor muscle invasion
low or intermediate risk NMIBC

Sites / Locations

Urology and Nephrology Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

High risk NMIBC

Arm Description

Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered

Outcomes

Primary Outcome Measures

Initial BCG complete response

free cystoscopy/negative cytology at 3 months.

Recurrence

Recurrence is defined as development of new tumor/positive cytology in patients with ICR

Progression

persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response

Secondary Outcome Measures

Full Information

NCT ID

NCT04723121

First Posted

January 20, 2021

Last Updated

January 22, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04723121

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2013 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Bladder cancer, Bacillus Calmette-Guérin response, Prediction, Urinary cytokines, T cells, Recurrence, Progression

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High risk NMIBC

Arm Type

Other

Arm Description

Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered

Intervention Type

Diagnostic Test

Intervention Name(s)

Urine ELISA for immunological markers (IL-2 and IL-10)

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis

Intervention Description

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-α, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control

Primary Outcome Measure Information:

Title

Initial BCG complete response

Description

free cystoscopy/negative cytology at 3 months.

Time Frame

3 months

Title

Recurrence

Description

Recurrence is defined as development of new tumor/positive cytology in patients with ICR

Time Frame

1 year

Title

Progression

Description

persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with primary or recurrent NMIBC for whom primary TURBT was done. Exclusion Criteria: Patients with previous BCG instillation, benign pathology Variant histology Non urothelial carcinoma, concommitent upper tract urothelial tumors, detrusor muscle invasion low or intermediate risk NMIBC

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amr A Elsawy

Organizational Affiliation

Urology and Nephrology Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansoura

State/Province

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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