An observational study in Renal Cell Carcinoma and Benign Renal Mass, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by RenJi Hospital · Observational
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.
Approximately 240 participants (acceptable range 200-250) will be enrolled before surgery. Plasma methylation testing will not guide clinical care and assay results will remain unavailable to treating clinicians and participants. The primary analysis compares pathologically confirmed renal cell carcinoma (RCC) with benign renal lesions. Non-RCC malignant renal lesions may be described separately. The final model is expected to contain 5-6 methylation markers. Model development, optimism correction, and cut-off stability will use at least 1,000 bootstrap resamples; the cohort will not be randomly divided into training and test sets. The marker combination, model coefficients or scoring algorithm, analytical quality-control rules, and positivity cut-off will be formally locked at study completion. This study is not an external validation study.
1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.
This study's planned enrollment of 240 is above the median of 146 across 363 observational studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.
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Adults with radiologically detected renal masses who are scheduled to undergo partial or radical nephrectomy as part of routine clinical care. Eligible participants will undergo preoperative peripheral blood collection for plasma DNA methylation analysis, and the final histopathological diagnosis of the resected renal lesion will serve as the reference standard. The study population will include patients with renal cell carcinoma and benign renal lesions, with prespecified enrichment of major RCC histological subtypes and benign renal lesions to support classifier development and threshold determination.
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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Patients with radiologically detected renal masses who are scheduled to undergo partial or radical nephrectomy as part of routine clinical care. Peripheral blood will be collected preoperatively for plasma DNA methylation analysis. Methylation assay results will be blinded and will not influence clinical management. Final histopathological diagnosis of the resected renal lesion will serve as the reference standard for classifier development and threshold determination.
Diagnostic performance of the final plasma DNA methylation classifier
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.
Time frame: At completion of enrollment and availability of final histopathology, anticipated within 3 months]
Sensitivity and specificity at the locked positivity threshold
Sensitivity for RCC and specificity for benign renal lesions, each with two-sided 95% confidence intervals, at the final positivity threshold selected during classifier development. Threshold selection will prioritize an RCC sensitivity of approximately 90%, where technically achievable, while maximizing specificity among thresholds satisfying this sensitivity constraint.
Time frame: At completion of classifier development, anticipated within 3 months]
Additional diagnostic performance measures
Accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for discrimination of RCC from benign renal lesions. Prevalence-dependent measures, including positive and negative predictive values, will be interpreted descriptively if enrichment of selected pathological categories is used.
Time frame: [Time Frame: At completion of classifier development, anticipated within 3 months]
Diagnostic performance across pathological and tumor subgroups
Sensitivity summarized by major RCC histological subtype, pathological stage, grade, and tumor-size category; specificity summarized by major benign pathological category.
Time frame: [Time Frame: At completion of classifier development, anticipated within 3 months]
Incremental performance beyond routine clinical and imaging variables
Change in discrimination and exploratory decision-curve analysis when the methylation score is added to prespecified clinical and radiological variables.
Time frame: At completion of classifier development, anticipated within 3 months]
Plan to share: Undecided — The final plan will be specified before study completion, subject to participant consent, institutional policy, applicable law, and protection of commercially sensitive assay-development information.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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