RecruitingNot Applicable

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

China84 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

extravesical recurrence free survival

Timeframe: 2 year

Trial details

NCT IDNCT05595408

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-03

Contact for this trial

jiwei huang, M.D

8613651682825 huangjiwei@renji.com

View on ClinicalTrials.gov More Muscle Invasive Upper Tract Urothelial Carcinoma trials