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

NCT ID: NCT02169349

Last Updated: 2016-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Stage IIIb and IV Non Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

Next Generation Sequencing

Intervention Type OTHER

DNA Analysis

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Mosser, PUPH

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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CHU

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00426-41

Identifier Type: -

Identifier Source: org_study_id

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