MIBC, NMIBC, UTUC
Conditions
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)
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.
Interventions
None listed
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort I: Inclusion Criteria: * 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UC MRD score | 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 | Provide 100 ml of morning urine for UC MRD testing at the appropriate collection node; assessment results were recorded as a score (0-100) |
Countries
China
Contacts
Primary ContactCuijian Zhang, MD.
Outcome results
None listed