NCT05029791 Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients
| NCT ID | NCT05029791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-18 |
| Primary Completion | 2031-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-08-18 with a primary completion date of 2031-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
COLEMAN is an opened prospective monocentric non-randomized study, initiated by the Hospices Civils de Lyon. Population targeted are patients from 18 years old with stage III or IV metastatic melanoma eligible for a metastatic melanoma treatment administered as part of usual care. The objective is to study the variations of immune infiltrate and cell plasticity before and under immunotherapy or targeted therapy. Two biopsies are done before and one month after the treatment initiation and one blood sample is done after the treatment initiation. 100 patients will be included and followed during 5 years.
Eligibility Criteria
Inclusion Criteria: * Patient age ≥ 18 * Female patients must agree to the use of 2 methods of contraception. For man one method of contraception is needed if if his partner is in childbearing age throughout the study and for at least 5 months after last study treatment administration. * Patients with metastatic stage III or IV melanoma relapse * Eligible for a melanoma metastatic treatment indicated and administered as part of usual care * Patients must be willing and able to undergo cutaneous tumor biopsies (except on the face and folds or lymph node) according to the study protocol * Patient insured or beneficiary of a health insurance plan * Patient able to provide informed consent and sign approved consent forms to participate in the study * Patient accepting the conservation of biological samples and their use for clinical research including genetic research Exclusion Criteria: * Hematologic tumours under treatment * Patients with a documented history of autoimmune pathology * Ocular melanoma * Persons placed under the safeguard of justice * Use of immunosuppressants including corticosteroids 4 weeks before the inclusion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05029791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05029791 currently recruiting?
Yes, NCT05029791 is actively recruiting participants. Contact the research team at Florence.guillemaud@chu-lyon.fr for enrollment information.
Where is the NCT05029791 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT05029791 clinical trial?
NCT05029791 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.