Non-Invasive Bladder Urothelial CarcinomaNCT05335512
Intravesical BCG: is the Urinary Bladder Ready to Receive it
An observational study of Non-Invasive Bladder Urothelial Carcinoma, run by Tata Memorial Centre.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Invasive Bladder Urothelial Carcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Frame after TURBT
To define the healing time-frame of the resected area of the bladder after TURBT.
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
Assessment Factors
To assess the factors influencing bladder healing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mahendra Pal, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335512
- Sponsor's protocol ID
- 3505
- Status last verified
- Jun 2022
- First submitted
- 12 Apr 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers but overall data will be published after the study completion.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical BCG: is the Urinary Bladder Ready to Receive it
- ClinicalTrials.gov ID
- NCT05335512
- Acronym / sponsor ID
- 3505
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time Frame after TURBT
Time frame: 1 year
To define the healing time-frame of the resected area of the bladder after TURBT.
2 secondary outcomes
Validate Grading System
Time frame: 1 year
Assessment Factors
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers but overall data will be published after the study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Invasive Bladder Urothelial Carcinoma, run by Tata Memorial Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahendra Pal, DNB (9757091924, mahen1197@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Frame after TURBT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.