RecruitingNCT06991868

A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)


Sponsor

Peking University First Hospital

Enrollment

300 participants

Start Date

Mar 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Months

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a urine test can detect early signs of bladder cancer coming back after surgery, instead of relying only on imaging or repeat procedures. **You may be eligible if...** - You are 18 or older and have been diagnosed with urothelial carcinoma (a type of bladder/urinary tract cancer) - You are scheduled for a routine follow-up visit after surgery, OR you have never been treated but are being monitored, OR you have cancer that cannot be removed - You are willing to provide a urine sample **You may NOT be eligible if...** - You have a urinary tract infection at the time of sample collection - You have received bladder-administered treatments (like BCG) within the past 4 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT06991868


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