Intravesical BCG: is the Urinary Bladder Ready to Receive it

NCT ID: NCT05335512

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2028-09-01

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.

Detailed Description

This study will be offered to patients who are coming to Tata Memorial Hospital (TMH) for management of Non Muscular Invasive bladder cancer. 10 patients who undergo Transurethral resection of Bladder tumour will be enrolled. Any patient who undergoes TURBT in TMH, found to have NMIBC and gives consent is eligible for the study. Patient who has visible tumor on first or any subsequent cystoscopy are not eligible.

100 patients (40 private category & 60 general category patients) will be recruited, and they will be planned for cystoscopy in the minor operation theater under antibiotic cover and local anaesthesia at 2nd week, 3rd week, 4th week after the date of TURBT.

Apprehensive or uncooperative patient will undergo procedure under general anaesthesia.

Patients having non healed bladder mucosa at 4 weeks will be reassessed after a further 1week by additional cystoscopy.Each time of cystoscopy a photo of the healing resected area will be captured and will be used to compare with the next photo in the same patient to see the progress of healing. These photos will be assess by two experienced uro-oncologist to characterize the healing status of bladder.This comparison will be used to establish a grading system of bladder healing. The remaining cystoscopies will be performed as per guidelines. Urine routine microscopy and culture/sensitivity will be done before every cystoscopy to rule out urinary tract infection and to quantify the numbers of white blood cells the WBC count will be correlated with the degree of inflammation and phases of healing as additional marker. Patients who have healed or near healed resection area on any cystoscopy as per study protocol will be given IVB in the same setting if the patient is stratified as high risk NMIBC. Patients who will be stratified as low-risk NMIBC and has healed resection area will not have further cystoscopy as per study protocol but will undergo cystoscopy later as per guideline's schedule. Any patient having unhealed resection on cystoscopy will be planned for next cystoscopy as per protocol and IVB will not be given at this cystoscopy.

Conditions

Non-Invasive Bladder Urothelial Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

1. Patient who has visible tumor on first or any subsequent cystoscopy.

2. On histopathology found to have muscle invasive bladder cancer.

3. Patient having urinary tract infection before cystoscopy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mahendra Pal

Professor Urology Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mahendra Pal, DNB

Role: CONTACT

mahen1197@gmail.com

9757091924

Other Identifiers

3505

Identifier Type: -

Identifier Source: org_study_id