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NCT Number: NCT04866680

Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Jean Minjoz, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Personalized Circulating DNA follow-up

Procedure

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

Primary outcomes

  1. Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment

    Time frame: 24 months

    Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

Personalized Circulating DNA Follow-up in Melanoma

Acronym: PERCIMEL

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 30, 2021
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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