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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, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date January 15, 2019
Study Start Date May 2005
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2013)
Mutational status of the EGFR pathway [ Time Frame: up to 1 year ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Mutational status of the EGFR pathway
Change History Complete list of historical versions of study NCT00899405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer
Official Title EGFR Pathway Mutations in Lung Cancer Patient Tumors and Blood
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Archival tissue specimens and blood samples
Sampling Method Non-Probability Sample
Study Population Patients with lung cancer
Condition Lung Cancer
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 31, 2013)
800
Original Estimated Enrollment
 (submitted: May 9, 2009)
200
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed lung cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • May have received prior EGFR inhibitors
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00899405
Other Study ID Numbers 225287
UCD-155
UCD-200412410
CDR0000583056 ( Other Identifier: UCD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, Davis
Study Sponsor University of California, Davis
Collaborators Not Provided
Investigators
Principal Investigator: Philip C. Mack, PhD University of California, Davis
PRS Account University of California, Davis
Verification Date January 2019