Using tumor DNA to predict disease recurrence and guide treatment in 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
This study is testing if analyzing tumor DNA from blood and urine can help predict if advanced upper tract urothelial carcinoma will come back and guide treatment for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05595408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage II-IV upper tract urothelial carcinoma who have undergone radical nephroureterectomy and are receiving adjuvant therapy.
Not a fit: Patients with a history of bladder cancer, severe comorbidities, or those who have not undergone radical nephroureterectomy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients with advanced UTUC, potentially enhancing survival rates.
How similar studies have performed: While the use of ctDNA and utDNA in monitoring MRD has shown promise in other cancers, this specific application in UTUC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: jiwei huang, M.D
- Email: huangjiwei@renji.com
- Phone: 8613651682825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.