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 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 12:23 AM
NCT ID:
NCT07124858
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 and over.
* Histologically confirmed colorectal adenocarcinoma with locally advanced disease and/or unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate/early access and ii) marketing authorisation and reimbursement in France.
* Obtain informed consent from the patient for the clinical-biological cohort.
* Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).
Exclusion Criteria:
* Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).
* Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).
* Pregnant or breast-feeding women.
* Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07124858
Study Brief:
Protocol Section:
NCT07124858