Back to resultsPersonalized Circulating DNA Follow-up in Melanoma (PERCIMEL) (PERCIMEL)
Primary Purpose
Melanoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized Circulating DNA follow-up
Sponsored by
About this trial
This is an interventional diagnostic trial for Melanoma focused on measuring Circulating tumour DNA, immunotherapy, targeted therapy
Eligibility Criteria
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
Sites / Locations
- CHU Jean Minjoz
- CGFL
- Chu Dijon
- Chru Lille
- Ghr Mulhouse Sud Alsace
- Institut de Cancerologie de LorraineRecruiting
- Chru Nancy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Personalized Circulating DNA follow-up
Arm Description
FFPE tissue sample + blood sample (20ml)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04866680
First Posted
March 9, 2021
Last Updated
February 1, 2023
Sponsor
Institut de Cancérologie de Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT04866680
Brief Title
Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)
Acronym
PERCIMEL
Official Title
Personalized Circulating DNA Follow-up in Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Circulating tumour DNA, immunotherapy, targeted therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized Circulating DNA follow-up
Arm Type
Experimental
Arm Description
FFPE tissue sample + blood sample (20ml)
Intervention Type
Procedure
Intervention Name(s)
Personalized Circulating DNA follow-up
Intervention Description
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 Outcome Measure Information:
Title
Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment
Description
Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MERLIN JEAN-LOUIS, PharmD, PhD
Phone
33 3 83 65 60 62
Email
jl.merlin@nancy.unicancer.fr
Facility Information:
Facility Name
CHU Jean Minjoz
City
Besançon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NARDIN CHARLEE, MD
Email
cnardin@chu-besancon.fr
Facility Name
CGFL
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HERVIEU ALICE, MD
Email
AHervieu@cgfl.fr
Facility Name
Chu Dijon
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEUDY GERALDINE, MD
Email
geraldine.jeudy@chu-dijon.fr
Facility Name
Chru Lille
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MORTIER LAURENT, MD
Email
laurent.mortier@chru-lille.fr
Facility Name
Ghr Mulhouse Sud Alsace
City
Mulhouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MICHEL CATHERINE, MD
Email
michelc@ghrmsa.fr
Facility Name
Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MERLIN JEAN LOUIS, PharmD,PhD
Phone
00 33 3 83 65 60 62
Email
jl.merlin@nancy.unicancer.fr
First Name & Middle Initial & Last Name & Degree
GEOFFROIS LIONNEL, MD
First Name & Middle Initial & Last Name & Degree
HARLE ALEXANDRE, PharmD
Facility Name
Chru Nancy
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GRANEL BROCARD FLORENCE, MD
Email
f.granel-brocard@chru-nancy.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)
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