NCT07189520Not yet recruiting
1. SAFE-AI ONCO-TRACK: Multimodal GenAI for Early Detection of Minimal Residual Disease and Recurrence in Gastrointestinal Oncology
SAFE-AI ONCO-TRACK: Multimodal GenAI for Early Detection of Minimal Residual Disease and Recurrence in Gastrointestinal Oncology
Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 16 Sept 2025
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Università Politecnica delle Marche
- Diseases
- Colorectal cancer
- NCT number
- NCT07189520
What you commit to
- Study type: Observational
- Planned participants: 700
- From 1 Jun 2026 to the primary completion date, 1 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of non-resectable or metastatic disease at enrollment (Excludes non-curative settings where the longitudinal biomarker protocol may not be feasible.)
- Failure to complete biospecimen donation or key follow-up timepoints (Maintains data integrity and model reliability.)
Other
- Emergency surgeries or treatment plans that deviate from standard protocols (To maintain data comparability.)
- Inability or refusal to provide informed consent (Essential for ethical compliance.)
Who the study is looking for
- Age ≥18 years (RC and EC are primarily adult-onset cancers, and adult inclusion aligns with ethical biospecimen collection and consent processes.)
- Histologically confirmed diagnosis of rectal or esophageal cancer (Confirms clinical relevance and eligibility for standard treatment pathways.)
- Treatment plan includes surgical resection with curative intent (Ensures applicability to MRD and outcome prediction tasks.)
- Undergoing standard-of-care neo-adjuvant or perioperative therapy (Ensures data consistency and relevance to response modelling.)
- Ability and willingness to provide informed consent for biospecimen and clinical data use (Meets ethical requirements for participation.)
- Availability for longitudinal blood sampling at T0 (baseline), T1 (3 months post-treatment), and T2 (6 months post-treatment) (Critical for temporal biomarker analysis.)
- Optional Inclusion: Access to tumor tissue (archival or fresh) for multi-omic profiling (Supports deep integrative biomarker discovery.)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.