Molecular Analysis of 150 Lung Adenocarcinoma

Lung Adenocarcinoma Clinical Trial

— LUNG-EST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02843711
• Other study ID #: 69HCL15_0161
• Status: Active, not recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 21, 2016
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: December 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults

• lung adenocarcinoma

• Surgical specimen

Exclusion Criteria:

• not adenocarcinoma subtype of lung cancer

• Tumour biopsy

• insufficient material for DNA extraction

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Anatomie et cytologie pathologiques Groupement hospitalier Est, Institut de cancérologie des Hospices civils de Lyon,	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic DNA Mutation	Mutations identified by the LungCarta Panel (Sequenom) at the time of diagnosis. DNA was extracted from the lung surgical specimen.	at diagnosis (Day 0)	Yes