Clinical trial · Interventional
Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)
Personalized Circulating DNA Follow-up in Melanoma
NCT04866680CI-TRIAL-00125047PERCIMELactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized Circulating DNA follow-up | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Personalized Circulating DNA follow-up
- description
- FFPE tissue sample + blood sample (20ml)
- interventionNames
- Procedure: Personalized Circulating DNA follow-up
Primary outcomes (1)
- measure
- Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment
- timeFrame
- 24 months
- description
- Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- BACKGROUNDGeoffrois L, Harle A, Sahki N, Sikanja A, Granel-Brocard F, Hervieu A, Mortier L, Jeudy G, Michel C, Nardin C, Huin-Schohn C, Merlin JL. Personalized follow-up of circulating DNA in resected stage III/IV melanoma: PERCIMEL multicentric prospective study protocol. BMC Cancer. 2023 Jun 16;23(1):554. doi: 10.1186/s12885-023-11029-4. PMID 37328818