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

NCT07189520 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-09-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Artificial Intelligence

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

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2030-06-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07189520 on ClinicalTrials.gov