Etude : EXOMA 2 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : EXOMA 2

Situation thérapeutique : Métastatique ou localement avancé

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 30/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude multicentrique, prospective, multi-organe, visant à évaluer l’apport clinique d’une analyse « complexe » versus une analyse « simple » de l’exome, pour aider à la décision thérapeutique dans le cadre de la médecine de précision

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The "simple" analysis of the exome can determine somatic and constitutional mutations. The major challenge lies in the translation of sequencing data into clinically relevant information allowing the clinician to guide his decision-making A "complex" analysis of the exome would provide access to structural DNA data, concerning mutational signatures, tumor mutational load, analysis of large deletions, loss of heterozygosity as well as amplification of certain genes which may have an impact on the management of patients.
No data available to date makes it possible to assess the clinical interest of the availability of its additional information resulting from a "complex" analysis compared to a "simple" analysis. The objective of the EXOMA study is to assess the proportion of patients for whom the proposed therapy is derived from its additional information (complex analysis) and would not have been possible with a classic exome analysis (simple analysis) .
We hereby formulate the hypothesis that a "complex" analysis on a population presenting a metastatic or locally advanced disease treated early (from the 1st line of treatment) will make it possible to determine therapeutic indications which could not be discovered with a "simple" analysis.

Phase : NA

Stade : Localement avancé à Métastatique

1, 2
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 1. Age ≥ 18 years old
2. Weight> 30 Kg
3. Histological or cytological evidence of the diagnosis of a metastatic or locally advanced solid tumor
4. Patient in 1st or 2nd line of treatment for metastatic or locally advanced disease
5. Tumor material available in sufficient and usable quantity for the analyzes required by the study
6. Request for exome analysis to be carried out when initiating the 1st or 2nd line of treatment (line initiated at the time of inclusion)
7. Life expectancy estimated to be probably ≥ 6 months.
8. WHO ≤ 1
9. Normal biological parameters
10. Patient capable and willing to follow all study procedures in accordance with the protocol
11. Patient having understood the purpose, risks and constraints of the study and having signed and dated the consent form
12. Patient affiliated to the social security scheme.
Criterion making it possible to definitively validate the inclusion
(inclusion in two stages):
13. Samples (tumor + blood) received by the CGFL within 15 days of signing the consent with sufficient quantity and quality to perform the exoma analysis.

Critères de non-inclusion : 1. Tumor material not available or biopsy not possible.
2. Inability to take a blood test.
3. Refusal of genetic analysis.
4. Patient likely to progress within 3 months of inclusion in the study.
5. History of HIV / HBV / HCV infection.
6. Patient already included in the EXOMA or EXOMA2 study.
7. Woman who is pregnant, may be, or is breastfeeding.
8. Persons deprived of their liberty or under guardianship (including curatorship).
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04614480
Promoteur :
Centre Georges François Leclerc de Dijon
Type de sponsor : Institutionnel
(CGFL) - 1 Rue du Professeur Marion
21000 DIJON

Coordonnateur :
Professeur François GHIRINGHELLI
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Professeur Nicolas PENEL

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 20/01/2021