Molecular Analysis of 150 Lung Adenocarcinoma (LUNG-EST)

July 21, 2016 updated by: Hospices Civils de Lyon

Molecular Analysis of 150 Lung Adenocarcinoma With Corresponding Histopathological and Clinical Data Available

LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung adenocarcinomas. For all patients, clinical data and histopathological data are available. The objective of this study is to characterize these lung adenocarcinomas by the LungCarta Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are correlated with clinical, histopathological and molecular data.

Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's expression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

152

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
      • Lyon, France, 69008
        • Anatomie et cytologie pathologiques Groupement hospitalier Est, Institut de cancérologie des Hospices civils de Lyon,

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults>18 years old with diagnosis of lung adenocarcinoma and treatment by surgery

Description

Inclusion Criteria:

  • Adults
  • lung adenocarcinoma
  • Surgical specimen

Exclusion Criteria:

  • not adenocarcinoma subtype of lung cancer
  • Tumour biopsy
  • insufficient material for DNA extraction

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adenocarcinoma
Tumour samples coming from patients harboring a lung adenocarcinoma diagnosed at the Hospices Civils de Lyon. Tumour samples are coming from lung surgery.
Genetic: Sequencing
Tumour samples are coming from routine histopathological procedure. They are used with consent of the patients. Genomic DNA extraction is performed from paraffin-embedded formalin-fixed (FFPE) tumour samples of lung adenocarcinoma. The genomic DNA mutations are identified by mass spectrometry array (Sequenom) using the LungCarta Panel. This panel could identify 214 mutations among 26 oncogenes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic DNA Mutation
Time Frame: at diagnosis (Day 0)
Mutations identified by the LungCarta Panel (Sequenom) at the time of diagnosis. DNA was extracted from the lung surgical specimen.
at diagnosis (Day 0)

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Marie BREVET, MD, Hospices Civils de Lyon

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

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0161

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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