NCT01124669

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

May 14, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

June 13, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

May 14, 2010

Last Update Submit

May 16, 2017

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

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

    1 mont

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

    1 month

Interventions

DNA analysisGENETIC
mutation analysisGENETIC
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 E2501

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

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

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christine Chung, MD

    Vanderbilt-Ingram 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 14, 2010

First Posted

May 17, 2010

Study Start

June 13, 2010

Primary Completion

July 13, 2010

Study Completion

July 13, 2010

Last Updated

May 17, 2017

Record last verified: 2017-05