Active, not recruiting
Not applicable
Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)
Condition(s) studied
Melanoma
Investigational drug(s) / intervention(s)
Personalized Circulating DNA follow-up
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
Study 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.
Eligibility
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).
Primary outcome measure(s)
- 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
Trial sites (8)
| Facility | City | Region | Status |
| CHU Jean Minjoz |
Besançon |
France |
|
| CGFL |
Dijon |
France |
|
| Chu Dijon |
Dijon |
France |
|
| Chru Lille |
Lille |
France |
|
| Ghr Mulhouse Sud Alsace |
Mulhouse |
France |
|
| Institut Godinot |
Reims |
France |
|
| Institut de Cancerologie de Lorraine |
Vandœuvre-lès-Nancy |
France |
|
| Chru Nancy |
Vandœuvre-lès-Nancy |
France |
|
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