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NCT05595408Recruiting

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 · Last updated 9 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
84 (estimated)
First submitted
22 Oct 2022
Start date
1 Feb 2022
Primary completion date
3 Nov 2025
Lead sponsor
RenJi Hospital
NCT number
NCT05595408

What you commit to

  • Study type: Observational
  • Planned participants: 84
  • From 1 Feb 2022 to the primary completion date, 3 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • a prior history of bladder or synchronous bladder cancer
  • Neoadjuvant therapy exposure

Other illness

  • Severe infection;
  • Severe heart disease;
  • Uncontrollable neurological or mental disorders;
  • Severe diabetes mellitus;
  • Patients with severe autoimmune diseases.

Other

  • Pregnant or lactating women, or patients who are fertile but do not take contraceptive measures;
  • No bilateral UTUC
  • Surveillance time \< month
  • \<2 postoperative MRD surveillance assessments

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RenJi Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.