Plasma DNA Methylation for Preoperative Classification of Renal Masses

NCT07874542 | Recruiting

• 1 other identifier: METH-RENAL
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma; Benign Renal Mass

Keywords

renal mass; renal cell carcinoma; DNA methylation; plasma; liquid biopsy; diagnostic classifier; threshold setting

Outcome Measures

Primary Outcomes (1)

• 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.

  At completion of enrollment and availability of final histopathology, anticipated within 3 months]

Secondary Outcomes (4)

• Sensitivity and specificity at the locked positivity threshold

  At completion of classifier development, anticipated within 3 months]

• Additional diagnostic performance measures

  [Time Frame: At completion of classifier development, anticipated within 3 months]

• Diagnostic performance across pathological and tumor subgroups

  [Time Frame: At completion of classifier development, anticipated within 3 months]

• Incremental performance beyond routine clinical and imaging variables

  At completion of classifier development, anticipated within 3 months]

Study Arms (1)

Patients With Renal Masses

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead
• Sun Yat-Sen University Cancer Center: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Preoperative peripheral blood; plasma cell-free DNA for methylation testing

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Jiwei H Jiwei Huang

CONTACT

8613651682825; jiweihuang@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-09

Locations

CN (1)