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A Multicenter, Prospective, Observational Study Evaluating the Accuracy of the Multimodal Foundation Model Renal-FM in Renal Cancer Imaging and Pathological Diagnosis

A Multicenter, Prospective, Observational Study Evaluating the Accuracy of the Multimodal Foundation Model Renal-FM in Renal Cancer Imaging and Pathological Diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114906
Enrollment
Unknown
Registered
2025-12-18
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Kidney cancer

Interventions

Renal-FM diagnosis evaluation group :None

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion Criteria for CT Imaging Diagnosis Assessment: (1) Age >= 18 years and = 18 years and <= 80 years; (2) Patients who underwent partial nephrectomy or radical nephrectomy at participating centers (Zhongshan Hospital Affiliated to Fudan University, Qilu Hospital of Shandong University, Linyi People's Hospital, Zhongshan Hospital Xiamen Branch); (3) Postoperative histopathological diagnosis confirmed as renal cell carcinoma; (4) Accessible, quality-standard hematoxylin and eosin (H&E)-stained pathological slides.

Exclusion criteria

Exclusion criteria: 1. Exclusion Criteria for CT Imaging Diagnosis Assessment: (1) Preoperative receipt of targeted therapy, immunotherapy, or chemoradiotherapy; (2) Preoperative receipt of interventional embolization; (3) Metastatic renal carcinoma with primary site not originating in the kidney; (4) CT image quality defects, including motion artifacts, metal artifacts, contrast agent issues, or technical failures; (5) Missing key baseline data (e.g., pathological report) or unclear pathological diagnosis. 2. Exclusion Criteria for Pathological Diagnosis Assessment: (1) Preoperative receipt of targeted therapy, immunotherapy, or chemoradiotherapy; (2) Preoperative receipt of interventional embolization; (3) Metastatic renal carcinoma with primary site not originating in the kidney; (4) Severe technical defects in H&E-stained slides; (5) Failure of digital scanning; (6) Missing key baseline data (e.g., pathological report).

Design outcomes

Primary

MeasureTime frame
The accuracy of Renal-FM in distinguishing benign from malignant and assessing aggressiveness on CT imaging; the accuracy of Renal-FM in determining pathological subtype and nuclear grade.;

Secondary

MeasureTime frame
The difference in accuracy between Renal-FM and conventional deep learning models as well as the non-kidney-specific pathological large model Gigapath in CT imaging and pathological diagnosis;The performance gap between Renal-FM and radiologists and pathologists in corresponding diagnostic tasks.;

Countries

China

Contacts

Public ContactGuo Jianming

Zhongshan Hospital, Fudan University

guo.jianming@zs-hospital.sh.cn+86 139 0167 6616

Outcome results

None listed

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