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NCT Number: NCT01124669

Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

RATIONALE: Studying samples of 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 research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

About this study

OBJECTIVES:

  • To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
  • To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.

OUTLINE: This is a multicenter study.

DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of refractory non-small cell lung cancer
  • Received sorafenib tosylate on protocol ECOG-E2501
  • Available blood specimens

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

DNA analysis

Genetic

mutation analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR

    Time frame: 1 mont

  2. Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 17, 2010
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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