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
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk); cohort III was patients with muscle-invasive bladder cancer (MIBC) to receive neoadjuvant therapy; and cohort IV was patients evaluated for complete response (CR) after standard trimodality therapy (TMT) treatment (i.e. patients with successful bladder preservation). Primary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence/metastasis; Cohort II: MRD score to assess the sensitivity and specificity of tumor recurrence; Cohort III: MRD score to assess the sensitivity and specificity of tumor remnants. Secondary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence subgroup and metastasis subgroup; Cohort II: MRD score to assess the sensitivity and specificity of different grades and stages of recurrent tumors; Cohort III: MRD scores to assess the sensitivity and specificity of different grades and stages of residual tumors.
CONDITIONS
Official 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 or older with full civil capacity at consent
- Provide urine samples for MRD testing at defined study visits
- Pathologically confirmed urothelial tumor meeting cohort-specific criteria (upper urinary tract for Cohort I; bladder for Cohorts II, III, IV)
- Cohort I: High-risk UTUC (pT3/4 or any TpN+), no more than 50% squamous, adenomatous, or sarcomatoid differentiation
- Cohort II: NMIBC (T1, Ta, or Tis), no more than 50% squamous or adenoidal differentiation, carcinoma in situ allowed
- Cohort III: MIBC patients planned for neoadjuvant therapy with evaluable lesions on imaging, standard radical cystectomy and lymph node dissection
- Cohort IV: Patients clinically assessed as complete response after TMT, retaining bladder without need for salvage cystotomy
You will not qualify if you...
- Pathology after surgery not meeting enrollment criteria
- Inability to attend regular reviews at study center within 1 year post-treatment
- Disagreement with regular cystoscopy and/or imaging follow-up
- Presence of definite tumor recurrence or metastasis before enrollment
- Concurrent active malignant diseases or history of other malignancies within 5 years (excluding treated basal cell carcinoma and cervical carcinoma in situ)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
C
Cuijian Zhang, MD.
CONTACT
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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