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Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer

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ClinicalTrials.gov Identifier: NCT00899405
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn more about DNA changes in patients with lung cancer.


Condition or disease
Lung Cancer

Detailed Description:

OBJECTIVES:

  • Examine the mutational status of the EGFR pathway in tumor and blood samples from patients with lung cancer.
  • Correlate the EGFR pathway mutations in these samples with clinical outcomes of these patients.

OUTLINE: Archived tumor tissue and blood samples are analyzed via PCR to detect EGFR pathway mutations in DNA.


Study Design

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EGFR Pathway Mutations in Lung Cancer Patient Tumors and Blood
Study Start Date : May 2005
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients with lung cancer
Collection of archival tumor specimen at the beginning of the study and collection of blood samples at the beginning of the study and then at regular intervals


Outcome Measures

Primary Outcome Measures :
  1. Mutational status of the EGFR pathway [ Time Frame: up to 1 year ]

Biospecimen Retention:   Samples With DNA
Archival tissue specimens and blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lung cancer
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed lung cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • May have received prior EGFR inhibitors
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899405


Locations
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer    916-734-3089      
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Philip C. Mack, PhD University of California, Davis
More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00899405     History of Changes
Other Study ID Numbers: 225287
UCD-155
UCD-200412410
CDR0000583056 ( Other Identifier: UCD )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018

Keywords provided by University of California, Davis:
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases