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

NCT06991868 | Recruiting

• 1 other identifier: UCMRD-010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

NMIBC; MIBC; UTUC

Keywords

high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk); muscle-invasive bladder cancer (MIBC)

Outcome Measures

Primary Outcomes (1)

• UC MRD score

  Provide 100 ml of morning urine for UC MRD testing at the appropriate collection node; assessment results were recorded as a score (0-100)

  Cohort I: At begin of Cycle 1 and end of Cycle 6 (each cycle 21 days); Cohort II: every 6 months after surgery until 12 months; Cohort III: Baseline and The first day of thest neoadjuvant ther Cohort IV: every 6 months after TMT therapy until 12 months

Study Arms (4)

Cohort I

1. patients ≥18 years of age with full civil capacity at the time of signing the informed consent form; 2. patients who provide a urine sample for MRD testing at the time of undergoing postoperative review; 3. 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+.

Cohort II

1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients who provided a urine sample for central testing when they underwent postoperative review; 3. 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).

Cohort III

1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients providing urine samples for centralized testing prior to each cycle of treatment during neoadjuvant therapy; 3. pathology type: a predominantly urothelial tumor with a TUR surgical pathology primary site in the bladder is required, and is permitted to contain no more than 50% squamous, adenomatous, or sarcomatoid differentiation (iii) Patients with pathologic stage T2 or MIBC on comprehensive imaging despite pathologic stage T1; 4. Radical cystectomy after neoadjuvant therapy, including bladder, prostate, and seminal vesicles in men and bladder and uterus in women; 5. lymph node dissection at least to the extent of the standard dissection for bladder cancer (including the area of the common iliac arteries below the bifurcation of the iliac arteries bilaterally and the area between the ipsoas and genitofemoral nerve to the ureter)

Cohort IV

1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients to provide a urine sample for centralized testing at each review visit; 3. pathology type: the TUR surgical pathology is required to be a predominantly uroepithelial tumor with a primary site in the bladder, and is allowed to contain no more than 50% squamous, adenomatous, or sarcomatous differentiation; 4. there should be a centralized imaging to assess a clinical assessment of MIBC prior to TMT treatment; 5. patients assessed as clinically CR after undergoing TMT who can continue to retain their bladder and do not require salvage cystotomy.

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+), non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk), and muscle-invasive bladder cancer (MIBC)

You may qualify if:

• 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+.

You may not qualify if:

• 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:
• 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)
• TUR pathology that does not meet the enrollment criteria;
• predictable inability to meet the regular review at our center within 1 year postoperatively;
• disagreement with regular cystoscopy and/or imaging (the content and type of imaging will be determined by the clinician);
• definite recurrence or metastasis already exists;
• concurrent combination of other active malignant neoplastic disease or a 5-year history of other malignant neoplastic disease history (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)
• Cohort III:

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Cuijian Zhang, MD.

CONTACT

+86 18511695818; surgeon_zhang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 28, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (1)