A Retrospective EGFR Mutation Status Study in Chinese NSCLC Patients Using Paired Plasma and Tissue Samples
June 24, 2011 updated by: Peking Union Medical College Hospital
EGFR mutations plays an essential role in EGFR-TKIs treatment.
However, for some patients, tissue samples are not available.
The purpose of this study is to determine whether blood sample is feasible for EGFR mutation detection.For late stage NSCLC, we hypothesis plasma sample is an alternative for detecting EGFR mutations.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 86-100730
- Peking Union Medical College Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Non-small cell lung cancer patients who were diagnosed or treated in Peking Union Medical College Hospital or Peking University People's Hospital
Description
Inclusion Criteria:
- Non-small cell lung cancer
- Available plasma and pathologically confirmed tissue slices(pre-chemo and pre-radio therapy)
- Informed Consent
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Early Stage
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Late Stage
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine the consistence of EGFR mutation status in paired tissue and plasma samples
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine the EGFR mutation status in Chinese NSCLC
Time Frame: 3month
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3month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mengzhao Wang, MD, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Study Registration Dates
First Submitted
June 24, 2011
First Submitted That Met QC Criteria
June 24, 2011
First Posted (Estimate)
June 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 24, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCC001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.