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Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT01123460
First received: May 13, 2010
Last updated: May 16, 2017
Last verified: May 2017
May 13, 2010
May 16, 2017
April 12, 2010
June 12, 2010   (Final data collection date for primary outcome measure)
Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response [ Time Frame: 1 month ]
Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response
Complete list of historical versions of study NCT01123460 on ClinicalTrials.gov Archive Site
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Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride
Measurement of Potential Biomarkers Predicting Erlotinib Response

RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.

OBJECTIVES:

  • To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride.

OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.

Observational
Observational Model: Other
Time Perspective: Retrospective
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Non-Probability Sample
Samples submitted for research from patients enrolled on E3503
Lung Cancer
  • Other: enzyme-linked immunosorbent assay
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
June 12, 2010
June 12, 2010   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer
  • Received erlotinib hydrochloride on clinical trial ECOG-E3503

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01123460
CDR0000670992
ECOG-E3503T2
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Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Principal Investigator: Steven M. Dubinett, MD Jonsson Comprehensive Cancer Center
Eastern Cooperative Oncology Group
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP