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Diagnostic Performance of RenalPath in Renal Carcinoma: A Prospective, Multicenter, Observational Validation Study

Diagnostic Performance of RenalPath in Renal Carcinoma: A Prospective, Multicenter, Observational Validation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116157
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Kidney cancer

Interventions

Gold Standard:The gold standard in this study is an expert consensus diagnosis based on postoperative pathological specimens.
Index test:The index test in this study is the "RenalPath: a foundational model for renal pathology". This model is an artificial intelligence-powered software for. Its core function is to perform ful

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years (inclusive); 2. Underwent partial nephrectomy or radical nephrectomy at the participating centers (Zhongshan Hospital Affiliated to Fudan University, Qilu Hospital of Shandong University, Linyi People's Hospital, Xiamen Branch of Zhongshan Hospital Affiliated to Fudan University); 3. Postoperative histopathological confirmation of renal cell carcinoma; 4. Availability of HE-stained pathological sections that meet quality standards

Exclusion criteria

Exclusion criteria: 1. Received neoadjuvant therapy such as targeted therapy, immunotherapy, radiotherapy, or chemotherapy before surgery; 2. Received interventional embolization therapy before surgery; 3. Metastatic renal cell carcinoma with non-renal primary lesions; 4. Severe technical defects in HE sections; 5. Failure of digital scanning; 6. Missing key baseline data, such as pathological reports, etc.

Design outcomes

Primary

MeasureTime frame
Area Under the Receiver Operating Characteristic Curve, AUC-ROC; sensitivity ;specificity ; accuracy;

Countries

China

Contacts

Public ContactJianming Guo

Zhongshan Hospital, Fudan University

guo.jianming@zs-hospital.sh.cn+86 21 5879 2346

Outcome results

None listed

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