Non Muscle Invasive Bladder CancerNCT06287541
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
A study testing Urine biomarker -Guided without reTURBT in people with Non Muscle Invasive Bladder Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- Urine biomarker -Guided without reTURBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Jul 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NMIBC who have undergone initial TURBT and are scheduled for reTURBT surgery as recommended by guidelines or chosen by their physicians;
- Patients who have tested negative for urine biomarkers after the initial TURBT and before the second TURBT;
- Age ≥ 18 years;
- Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results;
- Willingness to sign informed consent.
Who cannot join
- Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
- Patients previously diagnosed with muscle-invasive bladder cancer;
- Patients unable to undergo a second transurethral resection;
- Patients with incomplete sample pathology information;
- Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements;
- Patients unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qiang Lv, Ph.D contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Qiang Lv, Ph.D, doctorlvqiang@sina.com
About this study
Official title: A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection of Bladder Tumor in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.
Read the detailed description
This clinical trial aims to address the clinical question of whether a urine biomarker test can effectively guide the decision-making process regarding the necessity of reTURBT (repeat transurethral resection of bladder tumor) in patients with non-muscle-invasive bladder cancer (NMIBC). The primary objective is to assess whether patients with negative urine biomarker tests can safely avoid reTURBT. Participants eligible for enrollment in this study will be randomized in a 1:2 ratio into two groups:Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT. Following reTURBT, they will also receive standard follow-up care. The main task for participants will involve providing urine samples for the biomarker test before reTURBT. Those in Group B will additionally undergo reTURBT, a standard surgical procedure involving the removal of residual tumor tissue from the bladder.Throughout the study period, researchers will assess their recurrence-free survival rates and RFS. The goal is to determine whether the urine biomarker test can safely spare patients from unnecessary reTURBT while maintaining comparable RFS rates. This study adheres to ethical guidelines and has obtained approval from the appropriate institutional review boards. Participant confidentiality and data integrity will be strictly maintained throughout the study duration. The results of this trial have the potential to inform clinical practice guidelines and improve the management of NMIBC patients by offering a personalized approach to treatment decision-making.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- Urine biomarker -Guided without reTURBT
- Keywords
- reTURBT; NMIBC; urine biomarker; RFS
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Fanconi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine biomarker -Guided without reTURBTProcedure or surgery
Participants will proceed without reTURBT
| Study group | Role | What they receive |
|---|---|---|
| Urine biomarker -Guided without reTURBT | Experimental | Participants in this arm will proceed without reTURBT. Receives: Procedure: Urine biomarker -Guided without reTURBT |
| Standard Care with reTURBT | No intervention | Participants in this arm will receive standard care, which undergo reTURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year RFS rate
the proportion of participants experiencing a recurrence during follow-up within 2 years
Measured: from initial TURBT to the first confirmed recurrence within 2 years
Secondary outcomes (1)
RFS
the duration from the completion of initial TURBT until the first recurrence of cancer is detected or until the end of the follow-up period, whichever comes first.
Measured: from initial TURBT to the first confirmed recurrence within 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 Mar 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- 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
- Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes.
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Lv, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287541
- Sponsor's protocol ID
- 2023-SR-486
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection of Bladder Tumor in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
- ClinicalTrials.gov ID
- NCT06287541
- Acronym / sponsor ID
- 2023-SR-486
- Conditions
- Non Muscle Invasive Bladder Cancer
- Keywords
- reTURBT; NMIBC; urine biomarker; RFS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 1 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.
The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.
Detailed description
This clinical trial aims to address the clinical question of whether a urine biomarker test can effectively guide the decision-making process regarding the necessity of reTURBT (repeat transurethral resection of bladder tumor) in patients with non-muscle-invasive bladder cancer (NMIBC). The primary objective is to assess whether patients with negative urine biomarker tests can safely avoid reTURBT. Participants eligible for enrollment in this study will be randomized in a 1:2 ratio into two groups:Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT. Following reTURBT, they will also receive standard follow-up care. The main task for participants will involve providing urine samples for the biomarker test before reTURBT. Those in Group B will additionally undergo reTURBT, a standard surgical procedure involving the removal of residual tumor tissue from the bladder.Throughout the study period, researchers will assess their recurrence-free survival rates and RFS. The goal is to determine whether the urine biomarker test can safely spare patients from unnecessary reTURBT while maintaining comparable RFS rates. This study adheres to ethical guidelines and has obtained approval from the appropriate institutional review boards. Participant confidentiality and data integrity will be strictly maintained throughout the study duration. The results of this trial have the potential to inform clinical practice guidelines and improve the management of NMIBC patients by offering a personalized approach to treatment decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes.
| Arm | Type | Receives |
|---|---|---|
| Urine biomarker -Guided without reTURBT | Experimental | Procedure: Urine biomarker -Guided without reTURBTParticipants in this arm will proceed without reTURBT. |
| Standard Care with reTURBT | No intervention | –Participants in this arm will receive standard care, which undergo reTURBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with NMIBC who have undergone initial TURBT and are scheduled for reTURBT surgery as recommended by guidelines or chosen by their physicians;
- Patients who have tested negative for urine biomarkers after the initial TURBT and before the second TURBT;
- Age ≥ 18 years;
- Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results;
- Willingness to sign informed consent.
Key exclusion criteria (6 listed)
- Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
- Patients previously diagnosed with muscle-invasive bladder cancer;
- Patients unable to undergo a second transurethral resection;
- Patients with incomplete sample pathology information;
- Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements;
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 |
|---|---|---|
| Urine biomarker -Guided without reTURBTParticipants will proceed without reTURBT | Procedure or surgery | Urine biomarker -Guided without reTURBT |
Primary outcome
2-year RFS rate
Time frame: from initial TURBT to the first confirmed recurrence within 2 years
the proportion of participants experiencing a recurrence during follow-up within 2 years
1 secondary outcome
RFS
Time frame: from initial TURBT to the first confirmed recurrence within 2 years
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 1 Mar 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Non Muscle Invasive Bladder Cancer
Active, not recruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
RecruitingPhase 2
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Active, not recruitingPhase 3
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
High-risk Non-muscle Invasive Bladder Cancer
RecruitingPhase 3
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Intermediate Risk Non-Muscle Invasive Bladder Cancer
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.
Qiang Lv, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine biomarker -Guided without reTURBT in people with Non Muscle Invasive Bladder Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Mar 2024. 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?
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 Qiang Lv, Ph.D (doctorlvqiang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year RFS rate (time frame: from initial TURBT to the first confirmed recurrence within 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 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.