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:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT02310451
Eligibility Criteria:
Inclusion Criteria:
* Subject of both sexes at least 18 years of age
* Patient with advanced melanoma unresectable (stage IIIc) or metastatic (stage IV)
* Patient for whom is considered a systemic treatment by BRAF inhibitor
* Patient no previously treated or no responding to chemotherapy with a last injection\> 1month
* Patient affected by a melanoma measurable according to version 1.1 of RECIST criteria
* Patient with a life expectancy superior than 3 months
* Serum pregnancy test negative for all women of childbearing age
* ECOG ≤1
* Patient affiliated to French social security
* Patient able to understand and communicate with the investigator and to comply with the requirements of the study
* Patient must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
Exclusion Criteria:
* Patients not eligible to a BRAF inhibitor therapy or affected by a serious disease wich could require a treatment susceptible to interfere with melanoma treatment
* Pregnant and lactating women
* Patient with active malignancy or a previous malignancy within the past 3 years; except for patient with resected BCC, resected cutaneous SCC, resected carcinoma in-situ of the cervix, and resected carcinoma in-situ of the breast
* Past medical history record of infection with human immunodeficiency virus or viral hepatite C or B
* Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02310451
Study Brief:
Protocol Section:
NCT02310451