Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)
Sponsor
Institut de Cancérologie de Lorraine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04866680
Collaborator
(none)
165
1
1
36
4.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
165 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Personalized Circulating DNA Follow-up in Melanoma
Anticipated Study Start Date
:
Oct 1, 2022
Anticipated Primary Completion Date
:
Oct 1, 2025
Anticipated Study Completion Date
:
Oct 1, 2025
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | France | 54519 |
Sponsors and Collaborators
- Institut de Cancérologie de Lorraine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier:
NCT04866680
Other Study ID Numbers:
- ICL-2021-01
First Posted:
Apr 30, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut de Cancérologie de Lorraine
Additional relevant MeSH terms: