Clinical Trials in China / NCT07874542
Recruiting
Observational
Plasma DNA Methylation for Preoperative Classification of Renal Masses
NCT07874542 · tracked via the Priya Life Science China tracker
Condition(s) studied
Renal Cell CarcinomaBenign Renal Mass
Study summary
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.
Eligibility
Inclusion Criteria:1.Age 18 years or older. 2.A renal mass identified by computed tomography and/or magnetic resonance imaging.
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.
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Exclusion Criteria:7.Systemic anticancer therapy, radiotherapy, local ablation, or surgery/pathological sampling of the index renal lesion before study blood collection.
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.
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Primary outcome measure(s)
- Diagnostic performance of the final plasma DNA methylation classifier — At completion of enrollment and availability of final histopathology, anticipated within 3 months]
Discrimination of the final plasma DNA methylation classifier for pathologically confirmed renal cell carcinoma versus benign renal lesions, assessed by the area under the receiver operating characteristic curve (AUROC) with a two-sided 95% confidence interval. Internal validation and correction for model optimism will be performed using at least 1,000 bootstrap resamples.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07874542 on ClinicalTrials.gov ↗ ← All trials in China