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Active, not recruiting Not applicable

Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)

NCT04866680 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-01-31
Last updated
2026-09-01

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Personalized Circulating DNA follow-up

Personalized Circulating DNA follow-up: FFPE tissue sample will be collected before and after surgery blood samples will be collected before and after surgery and every 3 to 4 months

Study summary

PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient; * ECOG performance status 0-2; * Patient with melanoma stage IIB or IIC, or any stage III, or stage IV that has been resected or is resectable; * Treatment-naïve patient (except for initial excisional biopsy performed for diagnostic purposes); * Patient scheduled to receive adjuvant therapy within 12 weeks following surgery, consisting of anti-BRAF and anti-MEK kinase inhibitors or anti-PD-1 monoclonal antibody immunotherapy, in accordance with marketing authorization; * Patient with stage IIIB, IIIC, IIID, or IV melanoma with macroscopic lesions (clinically or radiologically detectable) eligible for neoadjuvant therapy, surgery, and adjuvant therapy (according to current recommendations: ESMO and NCCN guidelines, and treatment regimens from the SWOG S1801 and NADINA studies); * Biological parameters compatible with the planned treatment; * Patient informed and having provided written informed consent. Exclusion Criteria: * Patient with mucosal melanoma or choroidal (uveal) melanoma; * Patient with another synchronous malignancy or who has been treated for another malignancy within the 3 years preceding informed consent (except carcinoma in situ of the cervix or resected cutaneous carcinoma); * Contraindication to a 30 mL blood sample; * Contraindication to surgery; * Contraindication to the proposed medical treatment (anti-BRAF and anti-MEK targeted therapies or immunotherapy); * Patient participating in another clinical trial involving an investigational medicinal product; * Pregnant or breastfeeding woman; * Patient deprived of liberty (including those under legal guardianship or curatorship).

Primary outcome measure(s)

  • Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment — 24 months
    Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting

Trial sites (8)

FacilityCityRegionStatus
CHU Jean Minjoz Besançon France
CGFL Dijon France
Chu Dijon Dijon France
Chru Lille Lille France
Ghr Mulhouse Sud Alsace Mulhouse France
Institut Godinot Reims France
Institut de Cancerologie de Lorraine Vandœuvre-lès-Nancy France
Chru Nancy Vandœuvre-lès-Nancy France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04866680 on ClinicalTrials.gov ↗ ← All trials in France