Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL) (PERCIMEL)

March 4, 2024 updated by: Institut de Cancérologie de Lorraine

Personalized Circulating DNA Follow-up in Melanoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
      • Dijon, France
      • Dijon, France
      • Lille, France
      • Mulhouse, France
        • Recruiting
        • Ghr Mulhouse Sud Alsace
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
        • Sub-Investigator:
          • HARLE ALEXANDRE, PharmD
        • Principal Investigator:
          • GEOFFROIS LIONNEL, MD
      • Vandœuvre-lès-Nancy, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized Circulating DNA follow-up
FFPE tissue sample + blood sample (20ml)
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01904-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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