NCT07874542Recruiting
Plasma DNA Methylation for Preoperative Classification of Renal Masses
METH-RENAL: A Prospective Clinical Development and Threshold-Setting Study of a Plasma DNA Methylation Classifier for the Preoperative Evaluation of Renal Masses
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT07874542
What you commit to
- Study type: Observational
- Planned participants: 240
- From 1 Sept 2026 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 8.Concurrent active malignancy requiring systemic treatment that, in the investigator's judgment, could materially interfere with interpretation of the methylation assay.
Other illness
- 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.
Other
- \-
Who the study is looking for
- 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.
- \-
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RenJi Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.