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

NCT02840604 | Completed

• 1 other identifier: EXOMA
• Study Type: observational
• Target: 795
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of exome analysis for patient with a malignant solid tumors

  Feasibility assess by whether or not the patient will have targeted therapeutic

  1 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with all types of solid malignant tumors not treatable metastatic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

CGFL

Dijon, 21079, France

Location

Related Publications (1)

• Ratovomanana T, Cohen R, Svrcek M, Renaud F, Cervera P, Siret A, Letourneur Q, Buhard O, Bourgoin P, Guillerm E, Dorard C, Nicolle R, Ayadi M, Touat M, Bielle F, Sanson M, Le Rouzic P, Buisine MP, Piessen G, Collura A, Flejou JF, de Reynies A, Coulet F, Ghiringhelli F, Andre T, Jonchere V, Duval A. Performance of Next-Generation Sequencing for the Detection of Microsatellite Instability in Colorectal Cancer With Deficient DNA Mismatch Repair. Gastroenterology. 2021 Sep;161(3):814-826.e7. doi: 10.1053/j.gastro.2021.05.007. Epub 2021 May 13.

  PMID: 33992635 DERIVED

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Pierre Fumoleau, Pr

  Centre Georges François Leclerc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: May 15, 2016
• Primary Completion: May 15, 2016
• Study Completion: April 29, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

FR (1)