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

July 27, 2020 updated by: Central Hospital, Nancy, France
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Meurthe Et Moselle
      • Vandœuvre-lès-Nancy, Meurthe Et Moselle, France, 54000
        • Centre hospitalier régional universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: over a period of 5 years (Day 0 = anatomopathological diagnosis)
Time (in months) from anatomopathological diagnosis to death
over a period of 5 years (Day 0 = anatomopathological diagnosis)
Progression Free survival
Time Frame: 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
over a period of 5 years (Day 0 = anatomopathological diagnosis)
Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma
Time Frame: 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
At base line (Day 0 = anatomopathological diagnosis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution in percentage of metastasis sites according oncogenic drivers
Time Frame: 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)
At baseline (Day 0 = anatomopathological diagnosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Director: Angelica Tiotiu, Nancy Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019PI224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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