NCT06287541Recruiting
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 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
Source: ClinicalTrials.gov · Last updated 1 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 428 (estimated)
- First submitted
- 23 Feb 2024
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Bladder cancer
- NCT number
- NCT06287541
What you commit to
- Study type: Interventional
- Planned participants: 428
- From 1 Jul 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously diagnosed with muscle-invasive bladder cancer;
- Patients unable to undergo a second transurethral resection;
Other illness
- Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
- Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements;
Other
- Patients with incomplete sample pathology information;
- Patients unable to provide written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.