NGS Genome Analysis in Personalisation of Lung Cancer Treatment (ALCAPONE)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample, biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, mutations, patients, mutations
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
Sites / Locations
- Centre Georges François Leclerc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
blood sample, biopsy
Arm Description
Outcomes
Primary Outcome Measures
search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS
Secondary Outcome Measures
comparison of genome profiles (mutations and rearrangements)
To compare gene profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) in primary lung tumors before treatment and when tumor progression on therapy according to treatment groups (targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation) using NGS methods
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)
Full Information
NCT ID
NCT02281214
First Posted
October 23, 2014
Last Updated
January 2, 2019
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT02281214
Brief Title
NGS Genome Analysis in Personalisation of Lung Cancer Treatment
Acronym
ALCAPONE
Official Title
Genome Analysis by Next Generation Sequencing in Personalisation of Lung Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2014 (Actual)
Primary Completion Date
November 17, 2014 (Actual)
Study Completion Date
November 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, mutations, patients, mutations
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
blood sample, biopsy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood sample, biopsy
Intervention Description
Blood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis
Primary Outcome Measure Information:
Title
search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS
Time Frame
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 Outcome Measure Information:
Title
comparison of genome profiles (mutations and rearrangements)
Description
To compare gene profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) in primary lung tumors before treatment and when tumor progression on therapy according to treatment groups (targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation) using NGS methods
Time Frame
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
Title
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)
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno COUDERT, MD, PhD
Organizational Affiliation
Centre Georges François Leclerc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
12. IPD Sharing Statement
Learn more about this trial
NGS Genome Analysis in Personalisation of Lung Cancer Treatment
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