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NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Genome Analysis by Next Generation Sequencing in Personalisation of Lung Cancer Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02281214
Acronym
ALCAPONE
Enrollment
165
Registered
2014-11-03
Start date
2014-10-24
Completion date
2018-11-17
Last updated
2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, mutations, patients, mutations

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.

Interventions

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

Sponsors

Centre Georges Francois Leclerc
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGSsearch 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

MeasureTime frameDescription
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 mutationTo 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)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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026