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

Adenocarcinoma of Lung Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493827
• Other study ID #: 2019PI224
• Status: Completed
• Start date: January 2011
• Est. completion date: December 2019

Study information

• Verified date: June 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Vandœuvre-lès-Nancy	Meurthe Et Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Time (in months) from anatomopathological diagnosis to death	over a period of 5 years (Day 0 = anatomopathological diagnosis)
Primary	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)
Primary	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	Distribution in percentage of metastasis sites according oncogenic drivers	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)	At baseline (Day 0 = anatomopathological diagnosis)