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Active Not Recruiting NCT04866680

Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)

Conditions: Melanoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 136
Sponsor: Institut de Cancérologie de Lorraine

Location: CHU Jean Minjoz Besançon

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 Criteria

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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04866680). StuddyBuddy aggregates publicly available trial information.