Lung AdenocarcinomaLUNG-ESTNCT02843711
Molecular Analysis of 150 Lung Adenocarcinoma
An observational study of Lung Adenocarcinoma, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Sequencing
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults>18 years old with diagnosis of lung adenocarcinoma and treatment by surgery
Who may be able to join
- Adults
- lung adenocarcinoma
- Surgical specimen
Who cannot join
- not adenocarcinoma subtype of lung cancer
- Tumour biopsy
- insufficient material for DNA extraction
Trial locations and contacts
1 site in 1 country.
France1 site
Anatomie et cytologie pathologiques Groupement hospitalier Est, Institut de cancérologie des Hospices civils de Lyon,
Lyon, 69008
About this study
Official title: 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.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Sequencing
- Keywords
- Lungcarta Panel, lung adenocarcinoma
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Adenocarcinoma | Tumour samples coming from patients harboring a lung adenocarcinoma diagnosed at the Hospices Civils de Lyon. Tumour samples are coming from lung surgery. Receives: Genetic: Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic DNA Mutation
Mutations identified by the LungCarta Panel (Sequenom) at the time of diagnosis. DNA was extracted from the lung surgical specimen.
Measured: at diagnosis (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie BREVET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843711
- Sponsor's protocol ID
- 69HCL15_0161
- Acronym
- LUNG-EST
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of 150 Lung Adenocarcinoma With Corresponding Histopathological and Clinical Data Available
- ClinicalTrials.gov ID
- NCT02843711
- Acronym / sponsor ID
- LUNG-EST / 69HCL15_0161
- Conditions
- Lung Adenocarcinoma
- Keywords
- Lungcarta Panel, lung adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenocarcinoma | – | Genetic: SequencingTumour samples coming from patients harboring a lung adenocarcinoma diagnosed at the Hospices Civils de Lyon. Tumour samples are coming from lung surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults>18 years old with diagnosis of lung adenocarcinoma and treatment by surgery
Key inclusion criteria (3 listed)
- Adults
- lung adenocarcinoma
- Surgical specimen
Key exclusion criteria (3 listed)
- not adenocarcinoma subtype of lung cancer
- Tumour biopsy
- insufficient material for DNA extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SequencingTumour 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. | Genetic | Adenocarcinoma |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie BREVET, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic DNA Mutation (time frame: at diagnosis (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.