NCT01123460

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 13, 2010

Last Update Submit

May 16, 2017

Conditions

Lung Cancer

Keywords

non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response

    1 month

Interventions

enzyme-linked immunosorbent assayOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients enrolled on E3503

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Immunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Steven M. Dubinett, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 14, 2010

Study Start

April 12, 2010

Primary Completion

June 12, 2010

Study Completion

June 12, 2010

Last Updated

May 17, 2017

Record last verified: 2017-05