Molecular Diagnosis on Circulating Tumor DNA of Non-Small Cell Lung Cancer (ANTiCIPe)
September 9, 2016 updated by: Rennes University Hospital
Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rennes, France, 35000
- CHU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from patients receiving treatment for NSCLC at the Rennes Hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantity of circulating tumor DNA in serially collected plasma specimens.
Time Frame: 1 year
|
To evaluate the change of quantity of circulating tumor DNA during treatment.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean Mosser, PUPH, Rennes University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
June 4, 2014
First Submitted That Met QC Criteria
June 18, 2014
First Posted (Estimate)
June 23, 2014
Study Record Updates
Last Update Posted (Estimate)
September 12, 2016
Last Update Submitted That Met QC Criteria
September 9, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00426-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.