NGS Genome Analysis in Personalisation of Lung Cancer Treatment

NCT02281214 | Completed DMC

• 1 other identifier: 2014-A01163-44
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Keywords

lung cancer, mutations; patients; mutations

Outcome Measures

Primary Outcomes (1)

• search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS

  search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1,... mutations and ALK , ROS rearrangements by NGS methods before treatment and when tumor progression in patients with first line metastatic lung cancer therapy (chimiotherapy, targeted therapy)

Secondary Outcomes (2)

• comparison of genome profiles (mutations and rearrangements)

  comparison of genome profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, ...mutations and ALK , ROS rearrangements) between targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation

• tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) and circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements)

  To compare tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) with circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, ...mutations and rearrangements using NGS methods

Study Arms (1)

blood sample, biopsy

EXPERIMENTAL

Other: blood sample, biopsy

Interventions

blood sample, biopsy 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

blood sample, biopsy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, 21000, France

Location

Related Publications (1)

• 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.

  PMID: 37516818 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection; Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Bruno COUDERT, MD, PhD

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 3, 2014
• Study Start: October 24, 2014
• Primary Completion: November 17, 2014
• Study Completion: November 17, 2018
• Last Updated: January 4, 2019

Record last verified: 2018-12

Locations

FR (1)