Status:
NOT_YET_RECRUITING
1. SAFE-AI ONCO-TRACK: Multimodal GenAI for Early Detection of Minimal Residual Disease and Recurrence in Gastrointestinal Oncology
Lead Sponsor:
Università Politecnica delle Marche
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief 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 c...
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Justification in parenthesis):
- 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.)
- Exclusion Criteria:
- Diagnosis of non-resectable or metastatic disease at enrollment (Excludes non-curative settings where the longitudinal biomarker protocol may not be feasible.)
- 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.)
- Failure to complete biospecimen donation or key follow-up timepoints (Maintains data integrity and model reliability.)
Exclusion
Key Trial Info
Start Date :
June 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT07189520
Start Date
June 1 2026
End Date
June 1 2030
Last Update
September 24 2025
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