Actively Recruiting
A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)
Led by Peking University First Hospital · Updated on 2025-05-28
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, prospective observational study to monitor the recurrence of urothelial carcinoma, a type of urinary tract cancer. The study includes four patient groups: those with high-risk upper tract urothelial carcinoma (UTUC), patients with non-muscle invasive bladder cancer (NMIBC), patients with muscle-invasive bladder cancer (MIBC) undergoing neoadjuvant therapy, and patients who have achieved complete response after trimodality therapy (TMT) and preserved their bladder. The goal is to evaluate the sensitivity and specificity of a urinary microscopic residual disease (MRD) score for detecting tumor recurrence or residual disease. Participants provide urine samples for MRD testing at specific times depending on their group: before and after treatment cycles, or during regular postoperative reviews every six months up to one year. Imaging assessments are also used to confirm clinical status and disease presence, including evaluations before TMT or neoadjuvant therapy. The study observes patients undergoing standard treatments such as surgery, chemotherapy, and TMT without altering their care. During the study, patients undergo urine sample collection and imaging assessments at set intervals to monitor disease status. The MRD score is the main outcome measure, recorded at baseline and during treatment or follow-up visits. Researchers will analyze how well the MRD score predicts tumor recurrence, residual tumors, or metastases. The study lasts up to one year post-treatment with regular reviews and urinary testing, providing ongoing monitoring for participants while documenting their clinical outcomes.
CONDITIONS
Brief Title
A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older with full civil capacity at the time of signing informed consent
- Patients who provide urine samples for MRD testing during postoperative or treatment reviews
- Pathologically confirmed predominantly urothelial tumors in the upper urinary tract (pT3/4 or any TpN+) or bladder (including T1, Ta, Tis stages), allowing up to 50% squamous, adenomatous, or sarcomatoid differentiation depending on cohort
- For neoadjuvant therapy cohort: patients undergoing radical cystectomy and lymph node dissection per standard bladder cancer surgery
- Patients assessed as clinically complete responders after trimodality therapy who retain their bladder and do not require salvage cystotomy
You will not qualify if you...
- Pathology results that do not meet enrollment criteria for each cohort
- Inability or unwillingness to attend regular reviews and cystoscopy or imaging follow-ups within one year postoperatively
- Presence of definite tumor recurrence or distant metastases at enrollment
- Concurrent active malignant diseases or history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after treatment)
- Disagreement with regular cystoscopy and imaging as determined by clinicians
- For neoadjuvant therapy cohort: less than two cycles of neoadjuvant therapy, lack of standard surgical procedures, or no evaluable lesions before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants provide urine samples for microscopic residual disease (MRD) testing and undergo postoperative or treatment reviews to monitor recurrence of urothelial carcinoma.
Visits every 6 months after surgery or trimodality therapy depending on cohort
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
C
Cuijian Zhang, MD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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