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

  • France
      • Rennes, France, 35000
        • CHU

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.
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

Rennes University Hospital

Collaborators

Roche Pharma AG

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.

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