Plasma DNA Methylation to Classify Kidney Masses Before Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

METH-RENAL is a prospective observational study that develops a plasma DNA methylation classifier using blood collected before nephrectomy, with post-surgical pathology as the reference standard. The goal is to lock a 5-6 marker panel, its scoring algorithm, and a positivity cut-off, then validate it in a subsequent multicenter study. About 200-250 adults with a renal mass are enrolled to build and internally validate the classifier, using bootstrap methods for optimism correction. The test will not guide current clinical care and results will not be shared with treating clinicians or participants. Non-RCC lesions may be reported separately, and the study is not an external validation of an existing marker panel.

Why it matters

Who can join: the full rules

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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Where it's running

• Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jiwei H Jiwei Huang
• Email: jiweihuang@outlook.com
• Phone: 8613651682825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.