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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT03416933
Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 years of age and older
* Histologic proven advanced skin melanoma (Stage IV or stage IIIc inoperable) with BRAF V600 mutation
* Patient who will treated with combined kinase inhibitors (dabrafenib + trametinib).
* Patient able to stand a blood collection of 20 mL
* Ability to provide an informed written consent form
* Patient must be affiliated to a social security system
* Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.
Exclusion Criteria:
* Patient with mucosal melanoma
* Patient with non-metastatic skin melanoma (All stages except stage IV and stage III C inoperable)
* Patient with another synchronous cancer, or within 3 years
* Patient with a contraindication to blood collection of 20 mL
* Patient deprived of liberty or under supervision
* Patient unable to receive kinase inhibitor therapy
* Patient treated with another combined kinase inhibitors than dabrafenib and trametinib
* Pregnant or breastfeeding women
* Patient (man or woman) of childbearing age who does not agree to use of contraceptive methods validated during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03416933
Study Brief:
Protocol Section:
NCT03416933