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Personalized ctDNA Monitoring for Predicting Immunotherapy Outcomes in Advanced Non-Clear Cell Renal Cell Carcinoma

NCT07776483 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2026-08-20

No results posted yet for this study

Summary

This is a prospective, non-interventional observational cohort study evaluating the clinical utility of patient-specific circulating tumor DNA (ctDNA) monitoring in patients with advanced non-clear cell renal cell carcinoma (nccRCC) receiving immune checkpoint inhibitor-based systemic therapy. Tumor-informed personalized ctDNA assays will be developed based on tumor tissue and matched normal blood samples, and ctDNA will be longitudinally assessed at predefined time points during treatment. The primary objectives are to evaluate the associations of baseline ctDNA status with progression-free survival and objective response rate. Secondary and exploratory analyses will assess overall survival, disease control, duration of response, longitudinal ctDNA dynamics, radiographic tumor burden, and molecular progression.

Conditions

  • Non-Clear Cell Renal Cell Carcinoma

Interventions

DIAGNOSTIC_TEST

Patient-Specific Tumor-Informed ctDNA Monitoring

Tumor tissue and matched normal blood will undergo genomic analysis to identify patient-specific somatic variants for development of a personalized tumor-informed ctDNA assay. Longitudinal plasma samples will subsequently be analyzed for ctDNA during systemic therapy. The assay is used for research monitoring and does not determine treatment selection.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Hao Zeng, Doctor · West China Hospital

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-30
Completion
2028-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07776483 on ClinicalTrials.gov