Using tumor DNA to predict disease recurrence and guide treatment in advanced upper tract urothelial carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the dynamics of circulating tumor DNA (ctDNA) and urine tumor DNA (utDNA) as predictive biomarkers for minimal residual disease (MRD) in patients with muscle-invasive upper tract urothelial carcinoma (UTUC). A total of 103 patients will be recruited, and various biological samples will be collected at different time points, including preoperative, postoperative, and during adjuvant therapy. The study seeks to determine the relationship between MRD detection and the efficacy of adjuvant chemotherapy or immunotherapy, as well as its prognostic implications for patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: jiwei huang, M.D
• Email: huangjiwei@renji.com
• Phone: 8613651682825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.