Clinical Trials in China / NCT05595408
Recruiting
Observational
Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma
NCT05595408 · tracked via the Priya Life Science China tracker
Condition(s) studied
Muscle Invasive Upper Tract Urothelial Carcinoma
Investigational drug(s) / intervention(s)
Adjuvant chemotherapyadjuvant immunotherapy
Adjuvant chemotherapy: cisplatin/carboplatin-gemcitabine 4-6 cycles
adjuvant immunotherapy: immunotherapy for one year
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- extravesical recurrence free survival — 2 year
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | Recruiting |
More RenJi Hospital trials in China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05595408 on ClinicalTrials.gov ↗ ← All trials in China