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Compares treatment options for Non Muscle Invasive Bladder Cancer
Official title A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
ClinicalTrials.gov ID: NCT07036731
What this study is testing
- What it's testing
- This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled for a second resection. Within 1-6 weeks after the first resection and prior to the second resection, 100ml of routine urine will be collected and sent within 24 hours to Beijing Genetron Health Clinical Laboratory Co., Ltd.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or...
- Incomplete initial TURBT due to various reasons (including large tumor size, high risk of intraoperative bleeding, extensive tumor range, etc.)...
- Absence of muscle layer tissue in the initial resection specimen;
- Post-initial resection pathology indicating T1 stage;
- Post-initial resection pathology indicating G3/high-grade tumor, excluding pure carcinoma in situ;
You likely can't join if
- 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 resection;
- Patients with incomplete pathological information of the sample;
- Patients with contaminated samples;
- Patients whose urine samples fail quality control for valid reasons and cannot be resampled;
See the full eligibility criteria
- Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or physician's choice:
- Incomplete initial TURBT due to various reasons (including large tumor size, high risk of intraoperative bleeding, extensive tumor range, etc.), posing a risk of residual tumor;
- Absence of muscle layer tissue in the initial resection specimen;
- Post-initial resection pathology indicating T1 stage;
- Post-initial resection pathology indicating G3/high-grade tumor, excluding pure carcinoma in situ;
- Ability to provide a 100ml routine urine sample within 1-6 weeks after the initial resection and before the second resection;
- Age ≥ 18 years;
- Willingness to provide basic clinical information, pathology, and subsequent - recurrence monitoring results;
- Willingness to sign the informed consent form.
- 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 resection;
- Patients with incomplete pathological information of the sample;
- Patients with contaminated samples;
- Patients whose urine samples fail quality control for valid reasons and cannot be resampled;
- Any condition deemed by the investigator as potentially harming the subject or preventing the subject from meeting or fulfilling the study requirements;
- Patients unable to provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.