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What Benefit of a Full Analysis of Exome? Routine Care Study in Patients With Solid Tumors (EXOMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840604
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

The management of cancers and their therapeutic guidance was until shortly mostly based on histopathological considerations of the tumor. the development of targeted therapies is a turning point and keeps increase. These molecules target a specific molecular defect in the tumor making it more effective and more specific treatment. But these treatments are only effective if the tumor has a specific molecular abnormality that is characterized and known.

These therapeutic progresses have been made possible through the decoding of the human genome and the molecular defects occurring during the carcinogenesis process. Now, dozens of therapies targeting a specific molecular abnormality are available in the therapeutic arsenal and dozens more are under development in clinical trials Phase 1 to 3.

In recent years, the democratization of next generation sequencing has opened a new era in cancer research but also for molecular diagnostics. Indeed, the enormous sequencing capabilities offered by high-throughput sequencing technologies allow analysis in a limited time the entire coding sequence of the genome (exome), or even the entire genome of a tumor (whole genome sequencing). Thus, the evolution and the development of broadband and associated bioinformatics tools for genomics techniques now make it possible to establish the genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to propose and specifically targeted direct therapeutic identified genetic alterations and supposedly responsible for tumor development. An analysis of tumor exome by next-generation sequencing (NGS) and provides information on genetic modifications of these tumors.

This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this study is to evaluate the clinical benefit of an analysis of exome performed in current practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by quantifying the number of patients undergoing therapeutic proposal based on the results of the analysis of the profile of the tumor.


Condition or disease
Carcinoma

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Study Type : Observational
Actual Enrollment : 795 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: What Benefit of a Full Analysis of Exome? Routine Care Study in Patients With Solid Tumors
Actual Study Start Date : May 15, 2016
Actual Primary Completion Date : May 15, 2016
Actual Study Completion Date : April 29, 2019

Group/Cohort
patient with all types of solid malignant tumors not treatable
In the treatment or assessment of metastatic solid tumor malignancies not curable it can be offered to patients to establish the profile of their tumor by next generation sequencing (NGS). This technique permits the sequencing of millions of fragments in parallel in a short time and allows to identify rapidly somatic or constitutional mutations known or yet unknown. The establishment of the genetic profile of the tumor coupled to the available clinical data can help clinicians to predict patient outcome in terms of survival or progression to disease, but may also provide key clues to adapt the management and patient treatment.



Primary Outcome Measures :
  1. Feasibility of exome analysis for patient with a malignant solid tumors [ Time Frame: 1 month ]
    Feasibility assess by whether or not the patient will have targeted therapeutic



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with all types of solid malignant tumors not treatable metastatic
Criteria

Inclusion Criteria:

  • over 18 years
  • histological and cytological diagnosis of solid evidence of malignancy metastatic or locally advanced non-curable and non-curable
  • Disease for which a treatment under the national standards do not exist or will not exist if it escapes the current treatment
  • Availability of equipment or new tumor biopsy / puncture a feasible accessed injury (biopsiable disease), only if it is deemed necessary in the treatment by the investigator.
  • Patient affiliated with a social security scheme
  • Patient non opposition

Exclusion Criteria:

  • No tumor material available for the establishment of the tumor profile.
  • Patient refusal
  • Psychiatric illness and / or patient condition compromising the understanding of the information or the conduct of the study
  • Patient under guardianship or subject to major people protection regime

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840604


Locations
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France
CGFL
Dijon, France, 21079
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
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Study Director: Pierre Fumoleau, Pr Centre Georges François Leclerc
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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT02840604    
Other Study ID Numbers: EXOMA
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019