1. SAFE-AI ONCO-TRACK: Multimodal GenAI for Early Detection of Minimal Residual Disease and Recurrence in Gastrointestinal Oncology

Sponsor
Università Politecnica delle Marche
Study ID
NCT07189520
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Artificial Intelligence — OTHER
    Benchmark AI scoring vs expert raters (GEARS/OCHRA κ ≥0.75)• Assess performance gains after GenAI feedback (≥15% improvement)• Measure usability, cognitive load, and ecological footprint reduction

Study Details

Current decision tools (TNM, MRI/PET, CEA, and other serum markers, as well as single-marker genomics) are insufficiently predictive of responders, fail to detect early MRD in many cases, and rarely connect molecular biology to dynamic perioperative data. SAFE-AI will build and validate multimodal, explainable GenAI models that fuse liquid/tissue multi-omics with radiology and clinical trajectories to: (i) detect MRD earlier, (ii) improve recurrence-risk calibration, and (iii) support non-invasive "virtual biopsy"-inferring tissue-level features from blood profiles, and vice-versa, to mitigate missing-modality gaps. This is grounded in the strong mechanistic premise that integrating heterogeneous molecular signals with imaging captures tumour-host biology more completely than single-modality assays, enabling actionable, calibrated risk estimates for rectal and oesophageal cancer. The clinical hypothesis is that such integrated models can improve recurrence prediction by at least 20% over guideline baselines, with transparent uncertainty and bias monitoring to meet EU AI Act/MDR expectations.

Key Dates

First listed
Sep 24, 2025
Start date
Jun 1, 2026
Status verified
Sep 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2030

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: AI cohort
    Benchmark AI scoring vs expert raters (GEARS/OCHRA κ ≥0.75)• Assess performance gains after GenAI feedback (≥15% improvement)• Measure usability, cognitive load, and ecological footprint reduction

Primary Outcome Measure

Primary outcomes [ Time Frame: 24 months ]

Central Contacts

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