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OpenTrials
Completed

NCT Number: NCT02169349

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

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).

Completed

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Key information

Conditions

Stage IIIb and IV Non Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

next generation sequencing

Other

DNA analysis

Genetic

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA

Acronym: ANTiCIPe

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2014
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.