Intravesical BCG: is the Urinary Bladder Ready to Receive it
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTata Memorial Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Patients underwent TURBT
Trial outcomes
Primary outcomes
1
Time Frame after TURBT
To define the healing time-frame of the resected area of the bladder after TURBT.
Time frame
1 yearSecondary outcomes
1
Validate Grading System
The score is from grade 1 to grade 4, the title for grading 'Grading of healing with time', minimum value 1 is while maximum value 4 is and higher scores means a worst outcome
Time frame
1 year2
Assessment Factors
To assess the factors influencing bladder healing.
Time frame
1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: