Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)

Personalized Circulating DNA Follow-up in Melanoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04866680

Acronym

PERCIMEL

Enrollment

136

Registered

2021-04-30

Start date

2023-01-31

Completion date

2028-11-01

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Circulating tumour DNA, immunotherapy, targeted therapy

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.

Interventions

PROCEDUREPersonalized 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026