Status:
RECRUITING
A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)
Lead Sponsor:
Peking University First Hospital
Conditions:
NMIBC
MIBC
Eligibility:
All Genders
18+ years
Brief 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 urotheli...
Eligibility Criteria
Inclusion
- Cohort I:
- patients ≥18 years of age with full civil capacity at the time of signing the informed consent form;
- patients who provide a urine sample for MRD testing at the time of undergoing postoperative review;
- Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3/4 or any TpN+.
Exclusion
- Pathology after radical surgery that does not meet the criteria for enrollment;
- Predictable inability to meet the criteria for regular review at our center within 1 year postoperatively;
- Disagreement with regular cystoscopy and/or imaging (at least completion of one of CT or MR or PET/CT, with intervals between reviews as well as the specific items to be determined by the clinician);
- Already definite recurrence or metastasis;
- Concomitant combination of other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)
- Cohort II:
- Inclusion Criteria:
- patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
- patients who provided a urine sample for central testing when they underwent postoperative review;
- Pathological type: a pathologically confirmed predominantly uroepithelial tumor with a primary site in the bladder is required, and is permitted to contain no more than 50% squamous differentiation, or adenoidal differentiation carcinoma in situ is permitted to be present or only in situ and the pathologic stage may be T1, Ta, or Tis (Cis)
Key Trial Info
Start Date :
March 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06991868
Start Date
March 1 2024
End Date
May 31 2026
Last Update
May 28 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034