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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

Sponsor

RenJi Hospital

Enrollment

84 participants

Start Date

Feb 1, 2022

Study Type

OBSERVATIONAL

Conditions

Muscle Invasive Upper Tract Urothelial Carcinoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria11

  • 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

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Interventions

DRUGAdjuvant chemotherapy

cisplatin/carboplatin-gemcitabine 4-6 cycles

DRUGadjuvant immunotherapy

immunotherapy for one year

Locations(1)

Renji Hospital

Shanghai, Shanghai Municipality, China

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NCT05595408