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NCT04866680 Clinical Trial

Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)

Melanoma Clinical Trial

— PERCIMEL  

Official title:
Personalized Circulating DNA Follow-up in Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04866680
Other study ID # 2022-A01904-39
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2023
Est. completion date October 2025

Study information
Verified date March 2024
Source Institut de Cancérologie de Lorraine
Contact MERLIN JEAN-LOUIS, PharmD, PhD
Phone 33 3 83 65 60 62
Email jl.merlin@nancy.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 165
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - locally advanced, operable melanoma - treated by immunotherapy or anti-BRAF and anti-MEK targeted therapies (stage IIIb, IIIc) or exclusive immunotherapy (stage IV) in an adjuvant situation. Exclusion Criteria: - second cancer - woman who is pregnant, likely to be pregnant or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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

Locations
Country Name City State
France CHU Jean Minjoz Besançon
France CGFL Dijon
France Chu Dijon Dijon
France Chru Lille Lille
France Ghr Mulhouse Sud Alsace Mulhouse
France Chru Nancy Vandœuvre-lès-Nancy
France Institut de Cancerologie de Lorraine Vandœuvre-lès-Nancy

Sponsors (1)
Lead Sponsor Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting 24 months
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