NSCLC, Stage I, II, IIIA, IIIBTWISTlungNCT03509779
Pronostic and Predictive Value of EMT in Localized Lung Cancer
An observational study of NSCLC, Stage I, II, IIIA, IIIB and Surgery, run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
The goal of the present research is to identify an "EMT signature", associated with long term disease-free survival after surgery in NSCLC. This study will potentially lead to specific treatment recommendations, thanks to an integrated molecular approach including DNA, RNA and miR profiling In vitro analyses using… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NSCLC, Stage I, II, IIIA, IIIB, Surgery, Progression
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2014to 31 Dec 2025
- How long will I take part?
- 5 Years
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated by surgery at HEGP having signed the ONCOHEGP consent are eligible to this observational study
Who may be able to join
- Patient with NSCLC stage I II IIIA IIIB, treated by surgery at Georges Pompidou Hospital (HEGP) Informed consent ONCOHEGP signed
Who cannot join
- Informed consent ONCOHEGP not signed
Trial locations and contacts
1 site in 1 country.
Antoine Legras, MD PhD contact
France1 site, 1 recruiting
- Recruiting
Aphp Hegp
Paris, 75015
Helene Blons, PharmD PhD, 00 33 156095686, helene.blons@aphp.fr
Antoine Legras, MD PhD, antoine.legras@aphp.fr
About this study
Official title: EMT, Reactivation of Embryonic Transcription Factors and Alteration of the miR Signaling Network as Pronostic and Predictive Markers in Lung Cancer
The goal of the present research is to identify an "EMT signature", associated with long term disease-free survival after surgery in NSCLC. This study will potentially lead to specific treatment recommendations, thanks to an integrated molecular approach including DNA, RNA and miR profiling In vitro analyses using lung cancer cell lines will subsequently be conducted to validate markers identified in tumor screenings.
Read the detailed description
One critical issue in studying oncogenesis is the comprehensive understanding of tumor genome complexity. Molecular subtypes may be identified through large-scale molecular screenings or gene expression analyses and molecular signatures are recognized as a relevant source of disease stratification.
The investigators will focus on NSCLC patients with localized diseases included in the ONCOHEGP tissue collection project (OncoHEGP, Ministere de la Recherche n° DC 2009-950). The investigators had previously shown that in EGFR mutated cancer, reactivation of TWIST1 was reversibly linked to EMT and to survival. To go further, the investigators plane to investigate EMT in a large cohort of patients with lung cancer to identify prognostic and predictive markers of long term survival.
The investigators will integrate mutation, and copy number alterations to EMT gene expression analyses and to EMT related miR quantification. Tumor phenotype, miR signatures, mutation status will help classify patients according to survival.
Clinical data will be assessed thanks to the epithor database. Epithor is a government-recognized clinical database, accredited by the French Health Authorities (Haute Autorité de Santé) and is supported by the National Cancer Institute (Institut National du Cancer).
EMT characterization and scoring will be done using 10 markers by qPCR, mutation and CNV screenings by targeted NGS analysis, miRs signature by MIRSeq and qPCR.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | NSCLC localized disease treated by surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival
Time to relapse after surgery
Measured: 1 year
Overall survival
Time to death
Measured: 5 years
Secondary outcomes (1)
Overall survival
Time to death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start20 Oct 2014
- Primary completion31 Mar 2018
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLC, Stage I, II, IIIA, IIIBStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- APHP
- Responsible party
- Principal investigator, Hélène Blons, European Georges Pompidou Hospital
- Investigators
- Francoise Lepimpec Barthes, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509779
- Sponsor's protocol ID
- 2013-A01633-42
- Acronym
- TWISTlung
- Status last verified
- Sep 2018
- First submitted
- 17 Apr 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garinet S, Didelot A, Marisa L, Beinse G, Sroussi M, Le Pimpec-Barthes F, Fabre E, Gibault L, Laurent-Puig P, Mouillet-Richard S, Legras A, Blons H. A novel Chr1-miR-200 driven whole transcriptome signature shapes tumor immune microenvironment and predicts relapse in early-stage lung adenocarcinoma. J Transl Med. 2023 May 15;21(1):324. doi: 10.1186/s12967-023-04086-7.
PubMed 37189151
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMT, Reactivation of Embryonic Transcription Factors and Alteration of the miR Signaling Network as Pronostic and Predictive Markers in Lung Cancer
- ClinicalTrials.gov ID
- NCT03509779
- Acronym / sponsor ID
- TWISTlung / 2013-A01633-42
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Collaborators
- APHP
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Apr 2018 (actual)
- 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.
The goal of the present research is to identify an "EMT signature", associated with long term disease-free survival after surgery in NSCLC. This study will potentially lead to specific treatment recommendations, thanks to an integrated molecular approach including DNA, RNA and miR profiling In vitro analyses using lung cancer cell lines will subsequently be conducted to validate markers identified in tumor screenings.
Detailed description
One critical issue in studying oncogenesis is the comprehensive understanding of tumor genome complexity. Molecular subtypes may be identified through large-scale molecular screenings or gene expression analyses and molecular signatures are recognized as a relevant source of disease stratification.
The investigators will focus on NSCLC patients with localized diseases included in the ONCOHEGP tissue collection project (OncoHEGP, Ministere de la Recherche n° DC 2009-950). The investigators had previously shown that in EGFR mutated cancer, reactivation of TWIST1 was reversibly linked to EMT and to survival. To go further, the investigators plane to investigate EMT in a large cohort of patients with lung cancer to identify prognostic and predictive markers of long term survival.
The investigators will integrate mutation, and copy number alterations to EMT gene expression analyses and to EMT related miR quantification. Tumor phenotype, miR signatures, mutation status will help classify patients according to survival.
Clinical data will be assessed thanks to the epithor database. Epithor is a government-recognized clinical database, accredited by the French Health Authorities (Haute Autorité de Santé) and is supported by the National Cancer Institute (Institut National du Cancer).
EMT characterization and scoring will be done using 10 markers by qPCR, mutation and CNV screenings by targeted NGS analysis, miRs signature by MIRSeq and qPCR.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | –NSCLC localized disease treated by surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated by surgery at HEGP having signed the ONCOHEGP consent are eligible to this observational study
Key inclusion criteria (1 listed)
- Patient with NSCLC stage I II IIIA IIIB, treated by surgery at Georges Pompidou Hospital (HEGP) Informed consent ONCOHEGP signed
Key exclusion criteria (1 listed)
- Informed consent ONCOHEGP not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse free survival
Time frame: 1 year
Time to relapse after surgery
Overall survival
Time frame: 5 years
Time to death
1 secondary outcome
Overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 37189151Garinet S, Didelot A, Marisa L, Beinse G, Sroussi M, Le Pimpec-Barthes F, Fabre E, Gibault L, Laurent-Puig P, Mouillet-Richard S, Legras A, Blons H. A novel Chr1-miR-200 driven whole transcriptome signature shapes tumor immune microenvironment and predicts relapse in early-stage lung adenocarcinoma. J Transl Med. 2023 May 15;21(1):324. doi: 10.1186/s12967-023-04086-7.
- Individual participant dataSharing planned: No
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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.
Antoine Legras, MD PhD contact
Francoise Lepimpec Barthes, MD PhD principal investigator
APHP
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 NSCLC, Stage I, II, IIIA, IIIB and Surgery, run by European Georges Pompidou Hospital 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 1 inclusion and 1 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 6 Sep 2018. 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?
Contact Helene BLONS, PharmD PhD (00 33 156095686, helene.blons@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509779, which also lists 1 linked publication.
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 6 Sep 2018.