Skip to content

A multicenter, prospective clinical cohort study for the diagnosis of renal pelvis/sinus invasion in renal tumor based on blood/urine cfDNA methylation markers

A multicenter, prospective clinical cohort study for the diagnosis of renal pelvis/sinus invasion in renal tumor based on blood/urine cfDNA methylation markers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099944
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal tumor

Interventions

Gold Standard:Pathological Diagnosis
Index test:Methylation levels of specific biomarkers in patients' preoperative blood and urine cfDNA

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Case Group Patients: 1. Renal-origin tumors with clinical or radiological suspicion of renal pelvis/renal sinus invasion (radiologic findings indicate tumor base penetrating the renal medulla into the renal sinus, corresponding to clinical stage cT3); 2. Age 18–75 years, able to cooperate with surgical treatment; 3. Willing to provide written informed consent. Inclusion Criteria for Non-Case Group Patients: 1. Renal-origin tumors with no clinical or radiological evidence of renal pelvis/renal sinus invasion; 2. Age 18–75 years, able to cooperate with surgical treatment; 3. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Postoperative pathological diagnosis confirmed non-renal origin tumors; 2.Postoperative pathological diagnosis confirmed non-clear cell renal cell carcinoma; 3.Patients unsuitable for surgical treatment; 4.History of prior malignancy; 5.Patients with renal impairment, solitary kidney tumors, or post-renal transplant status; 6.Patients who received preoperative medical therapy.

Design outcomes

Primary

MeasureTime frame
Methylation levels of biomarkers in preoperative blood and urine cfDNA;Postoperative pathological findings;Sensitivity;Specificity;Positive predictive value;Negative predictive value;Accuracy;Area Under ROC Curve, AUC;Kappa Statistic;Likelihood Ratio;

Countries

China

Contacts

Public ContactQingbo Huang

Chinese PLA General Hospital

gdhuangqingbo@163.com+86 139 0427 5683

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026