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Blood test using DNA methylation to tell kidney cancer from benign kidney masses

Studies a blood test to classify kidney masses before surgery in adults.

Plain-language title generated from the registry record
Registry title: Plasma DNA Methylation for Preoperative Classification of Renal Masses

Key facts

Where
Shanghai, ChinaSee the site

Where in China

  • RenJi HospitalShanghai, ChinaTaking people

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Trial details

Who runs it
RenJi Hospital
Trial code
NCT07874542
Record updated
15 October 2026
Original description
METH-RENAL is a prospective observational diagnostic development and threshold-setting study in adults with a renal mass scheduled for partial or radical nephrectomy. Peripheral blood is collected before surgery, and postoperative histopathology serves as the reference standard. The study will develop and internally validate a plasma DNA methylation classifier and lock the final marker panel, algorithm, and positivity cut-off for a subsequent independent prospective multicenter validation study.Read full original descriptionShow less

METH-RENAL: A Prospective Clinical Development and Threshold-Setting Study of a Plasma DNA Methylation Classifier for the Preoperative Evaluation of Renal Masses

METH-RENAL is a prospective observational diagnostic development and threshold-setting study in adults with a renal mass scheduled for partial or radical nephrectomy. Peripheral blood is collected before surgery, and postoperative histopathology serves as the reference standard. The study will develop and internally validate a plasma DNA methylation classifier and lock the final marker panel, algorithm, and positivity cut-off for a subsequent independent prospective multicenter validation study.

Inclusion: 3.Partial nephrectomy or radical nephrectomy planned as part of routine clinical care; 4.Preoperative peripheral blood collection feasible before surgery or other treatment of the index lesion; 5.Final postoperative histopathological diagnosis expected to be available. 6.Written informed consent provided; -.

Exclusion: 8.Concurrent active malignancy requiring systemic treatment that, in the investigator's judgment, could materially interfere with interpretation of the methylation assay; 9.Severe acute infection or another uncontrolled systemic condition that could compromise biospecimen quality or study procedures; 10.Inadequate preoperative blood specimen or failure of prespecified analytical quality-control requirements; 11.No definitive pathological diagnosis of the index renal lesion. Any condition that, in the investigator's judgment, makes participation inappropriate; -.

ClinicalTrials.gov NCT07874542