NCT00897533

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment with erlotinib. PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

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 13, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung canceradenocarcinoma of the lungsquamous cell lung cancerbronchoalveolar cell lung cancer

Outcome Measures

Primary Outcomes (4)

  • Mesenchymal and epithelial markers

    Mesenchymal and epithelial markers

    1 month

  • Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression)

    Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers

    1 month

  • Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers

    Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers

    1 month

  • Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS

    Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS

    1 month

Interventions

gene mappingGENETIC
polymorphism analysisGENETIC
diagnostic laboratory biomarker analysisOTHER
immunohistochemistry staining methodOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients participating in E3503

DISEASE CHARACTERISTICS: * Diagnosis of non-small cell lung cancer, including any of the following subtypes: * Adenocarcinoma * Squamous cell carcinoma * Bronchoalveolar carcinoma * Carcinoid * Stage IIIB or IV or recurrent disease * Must have received treatment with 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

Related Publications (1)

  • Amann JM, Lee JW, Roder H, Brahmer J, Gonzalez A, Schiller JH, Carbone DP. Genetic and proteomic features associated with survival after treatment with erlotinib in first-line therapy of non-small cell lung cancer in Eastern Cooperative Oncology Group 3503. J Thorac Oncol. 2010 Feb;5(2):169-78. doi: 10.1097/JTO.0b013e3181c8cbd9.

    PMID: 20035238RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

Chromosome MappingAmplified Fragment Length Polymorphism AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Jill Kolesar, PharmD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 13, 2007

Primary Completion

April 13, 2008

Study Completion

April 13, 2008

Last Updated

May 19, 2017

Record last verified: 2017-05