Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

NCT ID: NCT02862743

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-14

Study Completion Date

2019-12-31

Brief Summary

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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

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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

Conditions

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Metastatic Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patients with metastatic melanoma

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

Group Type EXPERIMENTAL

patients with metastatic melanoma

Intervention Type OTHER

Blood sample to realize molecular characterization of melanoma

Interventions

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patients with metastatic melanoma

Blood sample to realize molecular characterization of melanoma

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Reims

Reims, , France

Site Status

Countries

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France

References

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Beaudoux O, Riffaud L, Barbe C, Grange F. Prognostic factors and incidence of primary mucosal melanoma: a population-based study in France. Eur J Dermatol. 2018 Oct 1;28(5):654-660. doi: 10.1684/ejd.2018.3398.

Reference Type RESULT
PMID: 30378540 (View on PubMed)

Other Identifiers

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PO15097*

Identifier Type: -

Identifier Source: org_study_id

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