High-Risk, Non-Muscle Invasive Bladder Urothelial CarcinomaNCT05276167
Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma
A study testing hyperthermic intravesical perfusion in people with High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma and Perfusion; Complications, run by Henan Cancer Hospital at 1 site in China.
Trial summary
To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma, Perfusion; Complications, Intraoperative Complications
- What is being tested?
- hyperthermic intravesical perfusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent for the trial.
- 18-75 years of age on day of signing informed consent.
- Have histologically confirmed muscle invasive disease of the urinary bladder.
- Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features.
- Clinical stage II-III and Have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy.
- Eastern Cooperative Oncology Group 0-1 and good organ function.
Who cannot join
- A non-surgical approach recommended by the treating urologist due to any reason.
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration.
- Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.
- Has a known additional malignancy that is progressing or required treatment ≤ 48 months of study registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has an active autoimmune disease requiring systemic treatment.
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- Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-programmed cell death 1, anti-programmed cell death-Ligand 1 antibody.
- Has a known history of Human Immunodeficiency Virus.
- Has known active Hepatitis B or Hepatitis C.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
BR-PRG
Zhengzhou, Henan, 450008
Huaqi Yin, MD., +8613366621170, yhq901212@163.com
About this study
Official title: The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis
To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.
Read the detailed description
The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.
After follow-up, the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety will be evaluated.
- Conditions
- High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma, Perfusion; Complications, Intraoperative Complications
- Being tested
- hyperthermic intravesical perfusion
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperthermic intravesical perfusionDevice
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Receives: Device: hyperthermic intravesical perfusion |
| The control group | No intervention | Participants in the control group will receive radical cystectomy alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intraoperative tumor cell dissemination
The rate of intraoperative tumor cell dissemination will be evaluated by lavage cytology of operating field
Measured: 3 years
Secondary outcomes (1)
Time to disease progression
Disease progression was defined as recurrence or metastasis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start6 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk, Non-Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Model description
- The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276167
- Sponsor's protocol ID
- Ytj20210926
- Status last verified
- Feb 2022
- First submitted
- 24 Nov 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis
- ClinicalTrials.gov ID
- NCT05276167
- Acronym / sponsor ID
- Ytj20210926
- Conditions
- High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma, Perfusion; Complications, Intraoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Mar 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.
To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.
Detailed description
The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.
After follow-up, the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Device: hyperthermic intravesical perfusionParticipants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. |
| The control group | No intervention | –Participants in the control group will receive radical cystectomy alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be willing and able to provide written informed consent for the trial.
- 18-75 years of age on day of signing informed consent.
- Have histologically confirmed muscle invasive disease of the urinary bladder.
- Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features.
- Clinical stage II-III and Have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy.
Key exclusion criteria (14 listed)
- A non-surgical approach recommended by the treating urologist due to any reason.
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration.
- Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.
- Has a known additional malignancy that is progressing or required treatment ≤ 48 months of study registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| hyperthermic intravesical perfusionParticipants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy | Device | The experimental group |
Primary outcome
Rate of intraoperative tumor cell dissemination
Time frame: 3 years
The rate of intraoperative tumor cell dissemination will be evaluated by lavage cytology of operating field
1 secondary outcome
Time to disease progression
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperthermic intravesical perfusion in people with High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma and Perfusion; Complications, run by Henan Cancer Hospital at 1 site in China.
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 6 inclusion and 14 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Huaqi Yin (+8613366621170, yhq901212@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intraoperative tumor cell dissemination (time frame: 3 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 16 Sep 2022.