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

Non-small Cell Lung Cancer Clinical Trial

— SITRR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02075957
• Other study ID #: 2012-A00827-36
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2014
• Last updated: February 27, 2014
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: February 2014
• Source: University Hospital, Angers
• Contact: José HUREAUX, Doctor
• Phone: 241353678
• Email: johureaux[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
France	UH Angers	Angers	Maine et Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes