Bladder CancerNCT06324058
Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
A study testing Transurethral cryoablation, Transurethral resection of bladder tumor and Bcg Intravesical in people with Bladder Cancer, run by Huashan Hospital.
Trial summary
This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Transurethral cryoablation, Transurethral resection of bladder tumor and Bcg Intravesical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2024to 18 Mar 2026
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 85, male or female;
- Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");
- Good compliance and able to cooperate with observation;
- Able to understand the purpose of the trial, agree to participate in this study, and have signed the informed consent form.
Who cannot join
- Patients with severe infectious diseases such as bacteremia and toxemia;
- Patients with severe coagulation dysfunction;
- Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;
- Patients with other concurrent malignancies;
- Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;
- Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage or above);
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- Preoperative assessment indicating distant metastasis or enlarged pelvic lymph nodes;
- Pregnant or breastfeeding women;
- Other situations assessed by researchers as unsuitable for inclusion in this study, such as inappropriate anatomical structure, mental or psychological disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.
- Conditions
- Bladder Cancer
- Being tested
- Transurethral cryoablation, Transurethral resection of bladder tumor, Bcg Intravesical
- 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.
Transurethral cryoablationProcedure or surgery
Using an intracavitary cryoablation balloon, cryoablation is performed on the wound surface after tumor resection. The wound surface is frozen for 2 rounds, with each round lasting 3 minutes, to fully cover the wound surface.
Transurethral resection of bladder tumorProcedure or surgery
Also called TURBt
Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer
Bcg IntravesicalDrug
Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines. At least 6 weeks induction instillation is required for high-risk NMIBC patients. At least 1 year maintenance instillation is recommended.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation group | Experimental | Transurethral resection of bladder tumor, instant cryoablation of the bladder tumor resection site. Receives: Procedure: Transurethral cryoablation; Procedure: Transurethral resection of bladder tumor; Drug: Bcg Intravesical |
| Control group | Active comparator | Transurethral resection of bladder tumor, conventional BCG instillation after surgery Receives: Procedure: Transurethral resection of bladder tumor; Drug: Bcg Intravesical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor residual rate
10-12 weeks after the initial TUR, Re-TUR or cystoscopy is performed on the original resection site, and a biopsy of the tissue at the original resection site is conducted to analyze and observe whether there is any tumor residue at the original tumor site.
Measured: 10-12 weeks after initial TURBt
Secondary outcomes (2)
Recurrence
Non-muscle invasive bladder cancer recurrence during follow-up
Measured: 2 years
Progression
Muscle invasive bladder cancer recurrence during follow-up
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 posted21 Mar 2024
- Study start18 Mar 2024 (estimated)
- Primary completion18 Mar 2025 (estimated)
- Study completion18 Mar 2026 (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 Huashan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haowen Jiang, Huashan Hospital
- Investigators
- Haowen Jiang, Pro., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324058
- Sponsor's protocol ID
- Huashan_H
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
- ClinicalTrials.gov ID
- NCT06324058
- Acronym / sponsor ID
- Huashan_H
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 18 Mar 2024 (estimated)
- Primary completion
- 18 Mar 2025 (estimated)
- Study completion
- 18 Mar 2026 (estimated)
- First posted
- 21 Mar 2024 (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.
This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation group | Experimental | Procedure: Transurethral cryoablation, Procedure: Transurethral resection of bladder tumor, Drug: Bcg IntravesicalTransurethral resection of bladder tumor, instant cryoablation of the bladder tumor resection site. |
| Control group | Active comparator | Procedure: Transurethral resection of bladder tumor, Drug: Bcg IntravesicalTransurethral resection of bladder tumor, conventional BCG instillation after surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 85, male or female;
- Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");
- Good compliance and able to cooperate with observation;
- Able to understand the purpose of the trial, agree to participate in this study, and have signed the informed consent form.
Key exclusion criteria (9 listed)
- Patients with severe infectious diseases such as bacteremia and toxemia;
- Patients with severe coagulation dysfunction;
- Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;
- Patients with other concurrent malignancies;
- Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;
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 |
|---|---|---|
| Transurethral cryoablationUsing an intracavitary cryoablation balloon, cryoablation is performed on the wound surface after tumor resection. The wound surface is frozen for 2 rounds, with each round lasting 3 minutes, to fully cover the wound surface. | Procedure or surgery | Cryoablation group |
| Transurethral resection of bladder tumorAlso: TURBtResection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer | Procedure or surgery | Control group, Cryoablation group |
| Bcg IntravesicalBacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines. At least 6 weeks induction instillation is required for high-risk NMIBC patients. At least 1 year maintenance instillation is recommended. | Drug | Control group, Cryoablation group |
Primary outcome
Tumor residual rate
Time frame: 10-12 weeks after initial TURBt
10-12 weeks after the initial TUR, Re-TUR or cystoscopy is performed on the original resection site, and a biopsy of the tissue at the original resection site is conducted to analyze and observe whether there is any tumor residue at the original tumor site.
2 secondary outcomes
Recurrence
Time frame: 2 years
Progression
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 21 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Haowen Jiang, Pro. principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral cryoablation, Transurethral resection of bladder tumor and Bcg Intravesical in people with Bladder Cancer, run by Huashan Hospital.
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 4 inclusion and 9 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 21 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shenghua Liu, Dr. (+8618101881202, 08301010098@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor residual rate (time frame: 10-12 weeks after initial TURBt). 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 21 Mar 2024.