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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02169349
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : September 12, 2016
Roche Pharma AG
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Stage IIIb and IV Non Small Cell Lung Cancer Other: laboratory biomarker analysis Other: Next Generation Sequencing Genetic: DNA Analysis

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA
Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from patients receiving treatment for NSCLC at the Rennes Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02169349

Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Roche Pharma AG
Principal Investigator: Jean Mosser, PUPH Rennes University Hospital

Responsible Party: Rennes University Hospital Identifier: NCT02169349     History of Changes
Other Study ID Numbers: 2014-A00426-41
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: October 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms