NCT04866680

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jan 2023Nov 2028

First Submitted

Initial submission to the registry

March 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

March 9, 2021

Last Update Submit

February 5, 2026

Conditions

Melanoma

Keywords

Circulating tumour DNAimmunotherapytargeted therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Personalized Circulating DNA follow-up

EXPERIMENTAL

FFPE tissue sample + blood sample (20ml)

Procedure: Personalized Circulating DNA follow-up

Interventions

Personalized Circulating DNA follow-upPROCEDURE

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

Personalized Circulating DNA follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHU Jean Minjoz

Besançon, France

Location

CGFL

Dijon, France

Location

Chu Dijon

Dijon, France

Location

Chru Lille

Lille, France

Location

Ghr Mulhouse Sud Alsace

Mulhouse, France

Location

Institut Godinot

Reims, 51100, France

Location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Chru Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

April 30, 2021

Study Start

January 31, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)