Bladder CancerPhase 3NCT02951078
A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer
A Phase 3 study testing Thulium Laser en Bloc Resection of bladder tumor and Electrical transurethral resection of bladder tumor in people with Bladder Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This study is to verify the short-term efficacy and long-term prognosis of thulium laser resection compared with conventional transurethral resection of non-muscular invasive bladder cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Thulium Laser en Bloc Resection of bladder tumor and Electrical transurethral resection of bladder tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathological or histological diagnosis of primary non-muscle invasive bladder urothelial carcinoma (TaTisT1);
- Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
- Patients who agree to TURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation;
- Function of main organs (heart, liver, lung, kidney) should be normal, PS score 0-2;
- Bladder capacity≥ 200ml.
Who cannot join
- Find distant metastasis ,infiltration of the surrounding organs or relapse before operation.Metastatic bladder cancer or other cancers involve the bladder;
- Received chemotherapy or BCG perfusion therapy in the nearly 3 months;
- Patients who can not tolerate the serious side effects during the bladder perfusion treatment process (bladder irritation and other symptoms);
- Patients during pregnancy ,critical care patients and patients who have other cases of surgical contraindications.Such as serious cardiovascular disease,coagulation abnormalities,non-transitional epithelial tumors( such as adenocarcinoma and squamous cell carcinoma),acute cystitis,can not be supine because of spinal deformity,untreated urethral stricture.
Trial locations and contacts
No sites are listed yet.
About this study
This study is to verify the short-term efficacy and long-term prognosis of thulium laser resection compared with conventional transurethral resection of non-muscular invasive bladder cancer. Half of participants will receive thulium laser resection of bladder cancer, while the other half will receive electrical transurethral resection of bladder cancer.
- Conditions
- Bladder Cancer
- Being tested
- Thulium Laser en Bloc Resection of bladder tumor, Electrical transurethral resection of bladder tumor
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Laser en Bloc Resection of bladder tumorProcedure or surgery
Electrical transurethral resection of bladder tumorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Thulium Laser en Bloc Resection of bladder tumor | Experimental | Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser Receives: Procedure: Thulium Laser en Bloc Resection of bladder tumor |
| Electrical transurethral resection of bladder tumor | Active comparator | Electrical transurethral resection of the Non-muscle Invasive Bladder tumor Receives: Procedure: Electrical transurethral resection of bladder tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The residual rate of tumor in the second operation of the two surgical methods
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Haitao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951078
- Sponsor's protocol ID
- ChiCTR-INR-16009513
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02951078
- Acronym / sponsor ID
- ChiCTR-INR-16009513
- Conditions
- Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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.
This study is to verify the short-term efficacy and long-term prognosis of thulium laser resection compared with conventional transurethral resection of non-muscular invasive bladder cancer. Half of participants will receive thulium laser resection of bladder cancer, while the other half will receive electrical transurethral resection of bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thulium Laser en Bloc Resection of bladder tumor | Experimental | Procedure: Thulium Laser en Bloc Resection of bladder tumorThulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser |
| Electrical transurethral resection of bladder tumor | Active comparator | Procedure: Electrical transurethral resection of bladder tumorElectrical transurethral resection of the Non-muscle Invasive Bladder tumor |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pathological or histological diagnosis of primary non-muscle invasive bladder urothelial carcinoma (TaTisT1);
- Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
- Patients who agree to TURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation;
- Function of main organs (heart, liver, lung, kidney) should be normal, PS score 0-2;
- Bladder capacity≥ 200ml.
Key exclusion criteria (4 listed)
- Find distant metastasis ,infiltration of the surrounding organs or relapse before operation.Metastatic bladder cancer or other cancers involve the bladder;
- Received chemotherapy or BCG perfusion therapy in the nearly 3 months;
- Patients who can not tolerate the serious side effects during the bladder perfusion treatment process (bladder irritation and other symptoms);
- Patients during pregnancy ,critical care patients and patients who have other cases of surgical contraindications.Such as serious cardiovascular disease,coagulation abnormalities,non-transitional epithelial tumors( such as adenocarcinoma and squamous cell carcinoma),acute cystitis,can not be supine because of spinal deformity,untreated urethral stricture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thulium Laser en Bloc Resection of bladder tumor | Procedure or surgery | Thulium Laser en Bloc Resection of bladder tumor |
| Electrical transurethral resection of bladder tumor | Procedure or surgery | Electrical transurethral resection of bladder tumor |
Primary outcome
The residual rate of tumor in the second operation of the two surgical methods
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thulium Laser en Bloc Resection of bladder tumor and Electrical transurethral resection of bladder tumor in people with Bladder Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Nov 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haitao Liu, chief physician (+86 15301655608, doctorlht69@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The residual rate of tumor in the second operation of the two surgical methods (time frame: 2 years). 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 1 Nov 2016.