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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02169349
Acronym
ANTiCIPe
Enrollment
100
Registered
2014-06-23
Start date
2014-06-30
Completion date
2016-09-30
Last updated
2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IIIb and IV Non Small Cell Lung Cancer

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).

Interventions

OTHERlaboratory biomarker analysis
OTHERNext Generation Sequencing
GENETICDNA Analysis

Sponsors

Roche Pharma AG
CollaboratorINDUSTRY
Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Mutation profiling of circulating tumor DNA from plasma samples.1 yearTo evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA.

Secondary

MeasureTime frameDescription
Quantity of circulating tumor DNA in serially collected plasma specimens.1 yearTo evaluate the change of quantity of circulating tumor DNA during treatment.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026