Renal Cell CarcinomaNCT07874542
Plasma DNA Methylation for Preoperative Classification of Renal Masses
An observational study of Renal Cell Carcinoma and Benign Renal Mass, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Benign Renal Mass
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200123
jiwei Huang J jiwei Huang, jiweihuang@outlook.com
About this study
Official title: METH-RENAL: A Prospective Clinical Development and Threshold-Setting Study of a Plasma DNA Methylation Classifier for the Preoperative Evaluation of Renal Masses
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.
Read the detailed description
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.
- Conditions
- Renal Cell Carcinoma, Benign Renal Mass
- Keywords
- renal mass, renal cell carcinoma, DNA methylation, plasma, liquid biopsy, diagnostic classifier, threshold setting
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At completion of enrollment and availability of final histopathology, anticipated within 3 months]
Secondary outcomes (4)
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.
Measured: 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.
Measured: [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.
Measured: [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.
Measured: At completion of classifier development, anticipated within 3 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874542
- Sponsor's protocol ID
- METH-RENAL
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METH-RENAL: A Prospective Clinical Development and Threshold-Setting Study of a Plasma DNA Methylation Classifier for the Preoperative Evaluation of Renal Masses
- ClinicalTrials.gov ID
- NCT07874542
- Acronym / sponsor ID
- METH-RENAL
- Conditions
- Renal Cell Carcinoma, Benign Renal Mass
- Keywords
- renal mass, renal cell carcinoma, DNA methylation, plasma, liquid biopsy, diagnostic classifier, threshold setting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of the final plasma DNA methylation classifier
Time frame: 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.
4 secondary outcomes
Sensitivity and specificity at the locked positivity threshold
Time frame: At completion of classifier development, anticipated within 3 months]
Additional diagnostic performance measures
Time frame: [Time Frame: At completion of classifier development, anticipated within 3 months]
Diagnostic performance across pathological and tumor subgroups
Time frame: [Time Frame: At completion of classifier development, anticipated within 3 months]
Incremental performance beyond routine clinical and imaging variables
Time frame: At completion of classifier development, anticipated within 3 months]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Benign Renal Mass, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwei H Jiwei Huang (8613651682825, jiweihuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the final plasma DNA methylation classifier (time frame: At completion of enrollment and availability of final histopathology, anticipated within 3 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.