NCT02075957

Brief Summary

Description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC).

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
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Typical duration 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 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

February 11, 2014

Last Update Submit

February 27, 2014

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer, adjuvant chemo-therapy, DNA chip

Outcome Measures

Primary Outcomes (11)

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    6 to 8 weeks after surgery

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 1 year

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 2 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 3 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 4 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 5 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 6 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 7 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 8 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 9 years

  • Determination of news microarrays profiles of NSCLC relapse risks

    The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.

    At 10 years

Eligibility Criteria

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

Patients with non small cell lung cancer

You may qualify if:

  • Major subject
  • Subject who received resection with primary non-small cell lung cancer at the University Hospital of Angers and whose tumor samples will be stored in collection of biological resources of University Hospital of Angers
  • A written inform consent.

You may not qualify if:

  • Under 18 year old;
  • Pregnant or nursing women;
  • Deprived of liberty;
  • Age under curatorship or guardianship;
  • Unable to consent person;
  • About not carrying a non-small cell lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Angers

Angers, Maine et Loire, 49933, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Three blood samples are going to be conserved : one during the week before the operation, one four to eight weeks next to the operation and the last one, at the relapse. * Biopsie of non small cell lung cancer will be conserved too.

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

  • José HUREAUX, Doctor

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José HUREAUX, Doctor

CONTACT

241353678johureaux@chu-angers.fr

Amandine AULNETTE, CRA

CONTACT

241358015amandine.aulnette@chu-angers.fr

Study Design

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

Study Record Dates

First Submitted

February 11, 2014

First Posted

March 3, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations

FR(1)