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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00899405
First received: May 9, 2009
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EGFR Pathway Mutations in Lung Cancer Patient Tumors and Blood

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Mutational status of the EGFR pathway [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Archival tissue specimens and blood samples


Estimated Enrollment: 800
Study Start Date: May 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00899405     History of Changes
Other Study ID Numbers: CDR0000583056, UCD-155, UCD-200412410
Study First Received: May 9, 2009
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014