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

May 6, 2024 updated by: University of California, Davis

EGFR Pathway Mutations in Lung Cancer Patient Tumors and Blood

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

800

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

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Cancer Center
        • Contact:
          • Clinical Trials Office - University of California Davis Cancer
          • Phone Number: 916-734-3089

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

Sampling Method

Non-Probability Sample

Study Population

Patients with lung cancer

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed lung cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • May have received prior EGFR inhibitors

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mutational status of the EGFR pathway
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

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

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Philip C. Mack, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2005

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimated)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225287
  • UCD-155
  • UCD-200412410
  • CDR0000583056 (Other Identifier: UCD)

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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