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

NCT04493827 | Completed

• 1 other identifier: 2019PI224
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Overall survival

  Time (in months) from anatomopathological diagnosis to death

  over a period of 5 years (Day 0 = anatomopathological diagnosis)

• Progression Free survival

  Time (in months) from anatomopathological diagnosis to progression of the disease assessed by RECIST criteria

  over a period of 5 years (Day 0 = anatomopathological diagnosis)

• Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma

  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

  At base line (Day 0 = anatomopathological diagnosis)

Secondary Outcomes (1)

• Distribution in percentage of metastasis sites according oncogenic drivers

  At baseline (Day 0 = anatomopathological diagnosis)

Eligibility Criteria

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

Study Population

Patients with metastatic lung adenocarcinoma diagnosed between 2012 and 2014 with a medical follow-up entirely done in Nancy Central Hospital

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54000, France

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Angelica Tiotiu

  Nancy Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 30, 2020
• Study Start: January 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-06

Locations

FR (1)