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OpenTrials
Completed

NCT Number: NCT04493827

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Régional Universitaire

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

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

    Time (in months) from anatomopathological diagnosis to death

  2. 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

  3. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2020
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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