NCT02448758

Brief Summary

The investigators propose to create a database at the regional level, the principle is to include all patients in whom a mutation was detected from a single platform (Lille). The creation of this regional cohort, smaller than the national cohort of Biomarkers France, will perform a more comprehensive collection of clinical data, and molecular monitoring data of patients included. To increase the completeness of the collection of information, it will not be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated to this activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 6, 2014

Last Update Submit

March 12, 2026

Conditions

Non-Small Cell Lung Cancer

Keywords

mutation

Outcome Measures

Primary Outcomes (1)

  • Correlation between clinical factors and mutation status

    The clinical factors are age, smoking status, occupational and environmental exposure, personal and family background, TNM stage, performance status

    at baseline

Secondary Outcomes (4)

  • Progression-free survival

    3 years

  • Overall survival

    3 years

  • Number of patients included in a clinical trial dedicated to a certain type of non-small cell lung cancer with mutation

    3 years

  • Number of cases per mutation type

    3 years

Eligibility Criteria

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

Non-small cell lung cancer with mutation of the Nord Pas de Calais

You may qualify if:

  • Aged ≥ 18 years old
  • Patient with non-small cell lung cancer
  • Detected in the Nord Pas de Calais
  • Monitored in the Nord Pas de Calais
  • Patient must have signed a non-opposition form to the use of medical data

You may not qualify if:

  • \- No identified mutation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Oscar Lambret

Lille, 59020, France

Location

CHRU

Lille, 59045, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alexis CORTOT, MD, PhD

    CHRU of Lille

    STUDY DIRECTOR

  • Eric Dansin, MD

    Centre Oscar Lambret

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2014

First Posted

May 19, 2015

Study Start

November 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

FR(2)