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Detection of Plasma DNA in Non Small Cell and Small Cell Lung Cancer Patients

Primary Purpose

Non-Small Cell Lung Carcinoma, Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy samples
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Non-Small Cell Lung Carcinoma focused on measuring Lung cancer, plasma DNA, allelotyping, follow-up, Prospective Study, Non-Small Cell Lung Cancer, Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Presence of lung tumor to use fiberoscopy or surgical intervention for diagnosis. No lung instability. Individuals give all informed consent

Sites / Locations

  • Service de Pneumologie, Hôpital Lyautey
  • Service de Chirurgie Thoracique, Hôpital Civil
  • Service de Pneumologie, Hôpital Civil
  • Service de Pneumologie, Hôpital de Hautepierre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
August 29, 2011
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT00213798
Brief Title
Detection of Plasma DNA in Non Small Cell and Small Cell Lung Cancer Patients
Official Title
Detection of Plasma DNA by Allelotyping in Non Small Cell and Small Cell Lung Cancer Patients. Evolution During Treatment and Follow-up.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

5. Study Description

Brief Summary
The majority of lung cancer patients have a tumor-derived genetic alteration in circulating plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate if plasma DNA can be used as a valuable non invasive test to monitor disease progression without assessing the tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Carcinoma, Small Cell Lung Cancer
Keywords
Lung cancer, plasma DNA, allelotyping, follow-up, Prospective Study, Non-Small Cell Lung Cancer, Small Cell Lung Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Biopsy samples

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of lung tumor to use fiberoscopy or surgical intervention for diagnosis. No lung instability. Individuals give all informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michèle BEAU-FALLER, MD
Organizational Affiliation
Service de Pneumologie, Hôpital de Hautepierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Pneumologie, Hôpital Lyautey
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Service de Chirurgie Thoracique, Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Pneumologie, Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Pneumologie, Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

Learn more about this trial

Detection of Plasma DNA in Non Small Cell and Small Cell Lung Cancer Patients

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