Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT07189520
Eligibility Criteria:
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.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07189520
Study Brief:
Protocol Section:
NCT07189520