NCT02843711

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 20, 2016

Last Update Submit

July 21, 2016

Conditions

Keywords

Lungcarta Panellung adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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

Interventions

SequencingGENETIC

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.

Adenocarcinoma

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Adults
  • lung adenocarcinoma
  • Surgical specimen

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, 69008, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin-embedded formalin fixed tumour sample

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Molecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Marie BREVET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 26, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations