Intravesical BCG: is the Urinary Bladder Ready to Receive it

NCT05335512 | Not Yet Recruiting DMC

• 1 other identifier: 3505
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective cohort and Prospective observational study which aims To define the healing time-frame of the resected area of the bladder after TURBT. and also to validate a grading system of healing of the bladder mucosa after TURBT. To assess the factors influencing bladder healing is also one of the secondary objectives.

Conditions

Non-Invasive Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time Frame after TURBT

  To define the healing time-frame of the resected area of the bladder after TURBT.

  1 year

Secondary Outcomes (2)

• Validate Grading System

  1 year

• Assessment Factors

  1 year

Study Arms (1)

Patients underwent TURBT

Patients undergoing complete TURBT for evaluation of a newly diagnosed bladder lesion in TMH and found to have NMIBC (either low risk or high risk)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be offered to patients who are coming to Tata Memorial Hospital (TMH) for management of NMIBC. Approx 10 patients who undergo TURBT in TMH will be enrolled in the pilot study as per study design. Based on validation of result of this study, proposed study will be carried out that will have 100 patients with same method including 10 patients of pilot study.

You may qualify if:

• Patients undergoing complete TURBT for evaluation of a newly diagnosed bladder lesion in TMH and found to have NMIBC (either low risk or high risk) Patient gives consent will be included (after explaining about the study).

You may not qualify if:

• Patient who has visible tumor on first or any subsequent cystoscopy.
• On histopathology found to have muscle invasive bladder cancer.
• Patient having urinary tract infection before cystoscopy

Sponsors & Collaborators

• Tata Memorial Centre: lead

Central Study Contacts

Mahendra Pal, DNB

CONTACT

9757091924; mahen1197@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Urology Oncology

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share