Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine

NCT ID: NCT04614480

Last Updated: 2025-09-22

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

7976 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2032-09-02

Brief Summary

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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 EXOMA2 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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Metastatic breast cancers

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic prostate cancers

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic lung cancers

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic colorectal cancers

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

metastatic otorhinolaryngeal cancer

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

metastatic ovarian cancer

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Pancreatic cancers

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Others metastatic cancers

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic sarcoma

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic gynecological cancer

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic renal cancer

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic cholangiocarcinoma metastatic

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic digestive cancer (other than stomach and colorectal)

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Metastatic stomach cancer

Group Type OTHER

Exome analysis

Intervention Type GENETIC

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Interventions

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Exome analysis

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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 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. Patient capable and willing to follow all study procedures in accordance with the protocol
10. Patient having understood the purpose, risks and constraints of the study and having signed and dated the consent form
11. Patient affiliated to the social security scheme.

Exclusion Criteria

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Georges Francois Leclerc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Coutant, PU-PH

Role: STUDY_DIRECTOR

Centre Georges François Leclerc

Locations

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CHU Amiens Picardie

Amiens, , France

Site Status NOT_YET_RECRUITING

CHRU Jean Minjoz

Besançon, , France

Site Status RECRUITING

Institut Bergonie

Bordeaux, , France

Site Status TERMINATED

Centre Henri Baclesse

Caen, , France

Site Status RECRUITING

CGFL

Dijon, , France

Site Status RECRUITING

CHU François Mitterrand

Dijon, , France

Site Status RECRUITING

Institut Hospitalier Franco-Britannique

Levallois-Perret, , France

Site Status TERMINATED

Centre Oscar Lambret

Lille, , France

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status TERMINATED

Chu Poitiers

Poitiers, , France

Site Status TERMINATED

Institut JeanGodinot

Reims, , France

Site Status RECRUITING

Centre Eugène Marquis

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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François Ghiringhelli, PU-PH

Role: CONTACT

+33(0)3 80 73 75 00

Emilie Rederstorff, PhD

Role: CONTACT

+33(0)3 80 73 75 00 ext. 34 61

Facility Contacts

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Bruno CHAUFFERT, MD

Role: primary

03 22 45 54 99

Laura MANSI, MD

Role: primary

03 70 63 24 03

Hubert CURCIO, Dr

Role: primary

0231455002

Emilie Rederstorff, PhD

Role: primary

+33(0)3 80 73 75 00 ext. 34 61

Antoine DROUILLARD, MD

Role: primary

03 80 29 37 50

Nicolas PENEL, MD

Role: primary

03 20 29 59 59

Stéphane VIGNOT, Dr

Role: primary

Antoine DELEUZE, Dr

Role: primary

0299253000

Other Identifiers

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2019-A02135-52

Identifier Type: -

Identifier Source: org_study_id

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