NGS Genome Analysis in Personalisation of Lung Cancer Treatment

NCT ID: NCT02281214

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-24
• Study Completion Date: 2018-11-17

Brief Summary

The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.

Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

blood sample, biopsy

Group Type: EXPERIMENTAL

blood sample, biopsy

Intervention Type: OTHER

Blood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis

Interventions

blood sample, biopsy

Blood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
• Patients with epidermoid cancer of the lungs can benefit from chemotherapy
• man and women
• age ≥ 18 years
• Patients have signed a written informed consent form
• Patients are affiliated to s social health insurance

Exclusion Criteria

• Survival time ≤ 3 months
• Patients with cerebral metastases
• Patients could not benefit from treatment for others diseases
• Pregnancy or breast-feeding
• Incapacity to sign the consent form for psychiatric, behavioural disorders
• Private individuals of freedom or under tutelage

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno COUDERT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Georges François Leclerc

Locations

Centre Georges François Leclerc

Dijon, , France

Countries

France

References

Dalens L, Niogret J, Richard C, Chevrier S, Foucher P, Coudert B, Lagrange A, Favier L, Westeel V, Kim S, Adotevi O, Chapusot C, Martin L, Arnould L, Kaderbhai CG, Boidot R. Durable response of lung carcinoma patients to EGFR tyrosine kinase inhibitors is determined by germline polymorphisms in some immune-related genes. Mol Cancer. 2023 Jul 29;22(1):120. doi: 10.1186/s12943-023-01829-4.

Reference Type: DERIVED

PMID: 37516818 (View on PubMed)

Other Identifiers

2014-A01163-44

Identifier Type: -

Identifier Source: org_study_id