Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer (SITRR)

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).

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer

Detailed Description

• A first blood sample will be taken during the week before the operation. A second blood sample will be taken 4 to 8 weeks after the operation. And in case of relapse, a third sample will be taken. These samples are going to be stored in the collection of biological resources of Angers.
• Concerning the biopsy of the resected NSLCL, it will be sent to the collection of biological resources of Angers for conservation directly next to the surgery.

• Study Type: Observational
• Enrollment (Anticipated): 192

Contacts and Locations

Study Locations

• France
  • Maine et Loire
    • Angers, Maine et Loire, France, 49933
      • Recruiting
      • UH Angers
      • Contact: José HUREAUX, Doctor; Phone Number: +33 2 41 35 36 78; Email: johureaux@chu-angers.fr
      • Contact: Amandine AULNETTE, CRA; Phone Number: +33 2 41 35 80 15; Email: amandine.aulnette@chu-angers.fr
      • Principal Investigator: José HUREAUX, Doctor
      • Sub-Investigator: Thierry URBAN, Professor
      • Sub-Investigator: Gonzague DE CHABOT, Doctor
      • Sub-Investigator: Cécile RIEUX, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with non small cell lung cancer

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: José HUREAUX, Doctor, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer, adjuvant chemo-therapy, DNA chip
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2012-A00827-36