Molecular Diagnosis on Circulating Tumor DNA of Non-Small Cell Lung Cancer

Completed

• Conditions: Stage IIIb and IV Non Small Cell Lung Cancer

• Registration Number: NCT02169349
• Lead Sponsor: Rennes University Hospital

Brief Summary

The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-23
• Status Verified: 2015-10
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Signed written informed consent
• Male or female aged >= 18 years
• Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed

Exclusion Criteria

• Tissue and plasma samples can not be provided for mutation analysis
• Unwilling or unable to provide informed consent
• Any serious medical condition that would interfere with the subject's safety

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mutation profiling of circulating tumor DNA from plasma samples.	1 year	To evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA.

Secondary Outcome Measures

Name	Time	Method
Quantity of circulating tumor DNA in serially collected plasma specimens.	1 year	To evaluate the change of quantity of circulating tumor DNA during treatment.

Trial Locations

Locations (1)

CHU; 🇫🇷 Rennes, France