NCT02169349CompletedNot Applicable
Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA
Rennes University Hospital1 site in 1 country100 target enrollmentStarted: June 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Mutation profiling of circulating tumor DNA from plasma samples.
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mutation profiling of circulating tumor DNA from plasma samples.
Time Frame: 1 year
To evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA.
Secondary Outcomes
- Quantity of circulating tumor DNA in serially collected plasma specimens.(1 year)
Investigators
Study Sites (1)
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