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Molecular Characterization of Advanced Stage Melanoma by Blood Sampling (MELCIRC)

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
patients with metastatic melanoma
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with melanoma confirmed histologically
  • patient with metastatic melanoma (stage III unresectable or stage IV)
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

Exclusion Criteria:

- Metastatic tumor whose origin is doubtful (uncertain melanoma)

Sites / Locations

  • Chu de Reims

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with metastatic melanoma

Arm Description

patients with metastatic melanoma (stage III unresectable or stage IV)

Outcomes

Primary Outcome Measures

Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood
Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)

Secondary Outcome Measures

Full Information

First Posted
August 8, 2016
Last Updated
September 16, 2022
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT02862743
Brief Title
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
Acronym
MELCIRC
Official Title
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

5. Study Description

Brief Summary
Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies. In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.
Detailed Description
The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood. The secondary objectives of this study will be: Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma. Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with metastatic melanoma
Arm Type
Experimental
Arm Description
patients with metastatic melanoma (stage III unresectable or stage IV)
Intervention Type
Other
Intervention Name(s)
patients with metastatic melanoma
Intervention Description
Blood sample to realize molecular characterization of melanoma
Primary Outcome Measure Information:
Title
Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood
Description
Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with melanoma confirmed histologically patient with metastatic melanoma (stage III unresectable or stage IV) patient consenting to participate to the study patient enrolled in the national healthcare insurance program patient older than 18 years Exclusion Criteria: - Metastatic tumor whose origin is doubtful (uncertain melanoma)
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

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Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

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