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NOT YET RECRUITING
NCT07888322

Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate

Sponsor: Aristotle University Of Thessaloniki

View on ClinicalTrials.gov

Summary

The COMFORT study will evaluate an artificial intelligence-based platform developed to support the clinical assessment of kidney and prostate cancer. The platform utilises imaging data to provide AI-generated outputs intended to assist clinicians in the assessment of suspected lesions. The primary objective of the study is to assess the role of the COMFORT platform in the clinical decision making process of clinicians managing kidney or prostate cancer cases. Secondary objectives include evaluation of the performance of AI models on anatomical segmentations, tumor characterisation (localisation, volumetric measurements, lesion classification, and scoring (e.g., Bosniak, PI-RADS, RENAL). Also the acceptability, usability, utility and trustworthiness of the AI models will be evaluated. In addition, potential causes of privacy leakage associated with the COMFORT AI models will be evaluated as part of the platform's privacy assessment.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-10-15

Completion Date

2027-02-28

Last Updated

2026-11-02

Healthy Volunteers

Yes

Interventions

OTHER

Medical Reading

Participants will perform medical reading of abdominal CT for renal cancer and prostate mpMRI for prostate cancer, without access to AI output using the COMFORT platform.

OTHER

AI assisted Medical reading

Participants will perform medical reading of abdominal CT for renal cancer and prostate mpMRI for prostate cancer, with access to AI output using the COMFORT platform.

Locations (6)

Klinikum rechts der Isar, TUM

München, Bavaria, Germany

Department of Neuroradiology, Charite

Berlin, State of Berlin, Germany

Department of Urology, University Hospital of Patras

Pátrai, Achaia, Greece

Laboratory of Medical Physics and Digital Innovation, School of Medicine

Thessaloniki, Central Macedonia, Greece

Department of Advanced Biomedical Sciences

Naples, Campania, Italy

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain