NCT03509779

Brief 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 lung cancer cell lines will subsequently be conducted to validate markers identified in tumor screenings.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 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

October 20, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

3.4 years

First QC Date

April 17, 2018

Last Update Submit

September 4, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Relapse free survival

    Time to relapse after surgery

    1 year

  • Overall survival

    Time to death

    5 years

Secondary Outcomes (1)

  • Overall survival

    3 years

Study Arms (1)

NSCLC

NSCLC localized disease treated by surgery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated by surgery at HEGP having signed the ONCOHEGP consent are eligible to this observational study

You may qualify if:

  • Patient with NSCLC stage I II IIIA IIIB, treated by surgery at Georges Pompidou Hospital (HEGP) Informed consent ONCOHEGP signed

You may not qualify if:

  • Informed consent ONCOHEGP not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aphp Hegp

Paris, 75015, France

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples analyzed for somatic mutations using NGS

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungDisease Progression

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francoise Lepimpec Barthes, MD PhD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene BLONS, PharmD PhD

CONTACT

Antoine Legras, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

October 20, 2014

Primary Completion

March 31, 2018

Study Completion

December 31, 2025

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations