Clinical trial · Observational
Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma
Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma(CURATE-UTUC): A Multicenter Prospective Longitudinal Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In our study, the ultra-deep sequencing of circulating tumor DNA (ctDNA) and urine tumor DNA (utDNA) were performed to assess whether ctDNA and utDNA can be used as predictive biomarkers for the detection of minimal residual disease (MRD) and early diagnosis of UTUC recurrence, and explored the role of ctDNA and utDNA detection of MRD in the prediction of adjuvant therapy efficacy and prognostic evaluation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle Invasive Upper Tract Urothelial Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| adjuvant immunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- adjuvant chemotherapy group
- description
- muscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant chemotherapy
- interventionNames
- Drug: Adjuvant chemotherapy
- label
- adjuvant immunotherapy group
- description
- muscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant immunotherapy
- interventionNames
- Drug: adjuvant immunotherapy
Primary outcomes (1)
- measure
- extravesical recurrence free survival
- timeFrame
- 2 year
- description
- The primary endpoint was extravesical recurrence-free survival (eRFS), defined as the time from radical nephroureterectomy (RNU) to the first occurrence of either locoregional recurrence (e.g., retroperitoneal lymph node, local soft tissue) or distant metastasis, as objectively confirmed by radiological imaging (CT or MRI) according to RECIST 1.1 criteria. Death from any cause without a prior documented extravesical recurrence was considered a competing risk event.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma * Male or female aged ≥18 years old who are willing to sign the informed consent form * have no distant metastasis * have an ECOG 0 to 2 * upper tract urothelial carcinoma patients received radical nephroureterectomy * have no multiple primary carcinoma * received adjuvant chemotherapy or immunotherapy after surgery within 12 weeks * ≥2 postoperative liquid biopsy assessments (T1 and T2) Exclusion Criteria: * a prior history of bladder or synchronous bladder cancer * Pregnant or lactating women, or patients who are fertile but do not take contraceptive measures; * Severe infection; * Severe heart disease; * Uncontrollable neurological or mental disorders; * Severe diabetes mellitus; * Patients with severe autoimmune diseases. * Neoadjuvant therapy exposure * No bilateral UTUC * Surveillance time \< month * \<2 postoperative MRD surveillance assessments
References
Publications (0)
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