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

ConditionCancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Georges Francois Leclerc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

Weight> 30 Kg

Histological or cytological evidence of the diagnosis of a metastatic or locally advanced solid tumor

Patient in 1st line of treatment for metastatic or locally advanced disease

Disqualifiers

Tumor material not available or biopsy not possible.

Inability to take a blood test.

Refusal of genetic analysis.

Patient likely to progress within 3 months of inclusion in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exome analysis

    Genetic

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

Treatment groups

7,976 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: Metastatic breast cancersOther 1 intervention
Group B: Metastatic prostate cancersOther 1 intervention
Group C: Metastatic lung cancersOther 1 intervention
Group D: Metastatic colorectal cancersOther 1 intervention
Group E: metastatic otorhinolaryngeal cancerOther 1 intervention
Group F: metastatic ovarian cancerOther 1 intervention
Group G: Pancreatic cancersOther 1 intervention
Group H: Others metastatic cancersOther 1 intervention
Group I: Metastatic sarcomaOther 1 intervention
Group J: Metastatic gynecological cancerOther 1 intervention
Group K: Metastatic renal cancerOther 1 intervention
Group L: Metastatic cholangiocarcinoma metastaticOther 1 intervention
Group M: Metastatic digestive cancer (other than stomach and colorectal)Other 1 intervention
Group N: Metastatic stomach cancerOther 1 intervention

Trial outcomes

Primary outcomes

1

proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis

Time frame
inclusion

Secondary outcomes

Other outcomes

Sponsors and contacts

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