Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL) (PERCIMEL)

Personalized Circulating DNA Follow-up in Melanoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma
• Intervention / Treatment: Procedure: Personalized Circulating DNA follow-up

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Chu Jean Minjoz
  • Dijon, France
    • CHU Dijon
  • Dijon, France
    • CGFL
  • Lille, France
    • CHRU Lille
  • Mulhouse, France
    • GHR Mulhouse Sud Alsace
  • Reims, France, 51100
    • Institut Godinot
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine
  • Vandœuvre-lès-Nancy, France
    • Chru Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Circulating DNA follow-up; FFPE tissue sample + blood sample (20ml)	Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy; targeted therapy; Circulating tumour DNA
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma
• Other Study ID Numbers: 2022-A01904-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No