Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma

NCT05595408 | Recruiting

• 1 other identifier: CURATE-UTUC
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Invasive Upper Tract Urothelial Carcinoma

Keywords

upper tract urothelial carcinoma; Minimal residual disease; Circulating tumor DNA; Urine tumor DNA; adjuvant chemotherapy; adjuvant immunotherapy

Outcome Measures

Primary Outcomes (1)

• extravesical recurrence free survival

  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.

  2 year

Secondary Outcomes (5)

• Lead time of molecular recurrence detection

  2 year

• intravesical recurrence free survival

  2 year

• recurrence-free survival

  2 year

• Overall survival

  2 year

• Diagnostic performance of MRD assay

  2 year

Study Arms (2)

adjuvant chemotherapy group

muscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant chemotherapy

Drug: Adjuvant chemotherapy

adjuvant immunotherapy group

muscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant immunotherapy

Drug: adjuvant immunotherapy

Interventions

Adjuvant chemotherapy DRUG

cisplatin/carboplatin-gemcitabine 4-6 cycles

adjuvant chemotherapy group

adjuvant immunotherapy DRUG

immunotherapy for one year

adjuvant immunotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma patients who received adjuvant chemotherapy or immunotherapy after radical nephroureterectomy

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead
• West China Hospital: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Central Study Contacts

jiwei huang, M.D

CONTACT

8613651682825; huangjiwei@renji.com

Study Design

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

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 27, 2022
• Study Start: February 1, 2022
• Primary Completion: November 3, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

CN (1)