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

  • China
      • Beijing, China, 86-100730
        • Peking Union Medical College Hospital

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
Early Stage
Late Stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the consistence of EGFR mutation status in paired tissue and plasma samples
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the EGFR mutation status in Chinese NSCLC
Time Frame: 3month
3month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Peking University People's Hospital

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.

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