Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center

Completed

• Conditions: Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic; Adenocarcinoma of Lung Stage IV

• Registration Number: NCT04493827
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for smoking habits. This region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other French regions. The objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the Nancy University Hospital Center metastatic lung adenocarcinoma's population.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Lung adenocarcinoma
• Patients diagnosed at a metastatic stage
• Patient who benefited an oncogenic driver research on their histologic samples
• Medical follow-up entirely done in Nancy Central Hospital

Exclusion Criteria

• Patients with double histology
• Synchronous cancer
• Patients with surgical care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	over a period of 5 years (Day 0 = anatomopathological diagnosis)	Time (in months) from anatomopathological diagnosis to death
Progression Free survival	over a period of 5 years (Day 0 = anatomopathological diagnosis)	Time (in months) from anatomopathological diagnosis to progression of the disease assessed by RECIST criteria
Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma	At base line (Day 0 = anatomopathological diagnosis)	Distribution in percentage of main oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2), assessed by Sanger sequencing or FISH method in histological samples from metastatic lung adenocarcinomas

Secondary Outcome Measures

Name	Time	Method
Distribution in percentage of metastasis sites according oncogenic drivers	At baseline (Day 0 = anatomopathological diagnosis)	Distribution in percentage of metastatic sites assessed by CT-scan for metastatic lung adenocarcinomas according oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2)

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire; 🇫🇷 Vandœuvre-lès-Nancy, Meurthe Et Moselle, France