NCT00897650

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2005

Completed
3.4 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
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

10.6 years

First QC Date

May 9, 2009

Last Update Submit

July 18, 2017

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

  • DNA, RNA, and Protein expression patterns and mutational analysis

    DNA, RNA, and Protein expression patterns and mutation status in lung tumor tissue that are capable of predicting tumor response to therapy

    After lung tumor tissue and blood collection.

Secondary Outcomes (1)

  • Characterization of genes and proteins predictive of response to therapy

    After lung tumor tissue and blood collection

Study Arms (1)

Lung cancer

Patients with a diagnosis of invasive lung cancer.

Genetic: DNA/RNA sequencing and expression levelsGenetic: Protein expression analysisProcedure: Lung tumor biopsyProcedure: Blood sample

Interventions

DNA/RNA sequencing and expression levelsGENETIC

Lung tumor tissue will be collected.

Lung cancer
Protein expression analysisGENETIC

Lung tumor tissue will be collected.

Also known as: Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI), Immunohistochemistry, Western blot, RPPA
Lung cancer
Lung tumor biopsyPROCEDURE

Tissue will be collected by percutaneous fine needle aspiration, a percutaneous core biopsy, or during a medically indicated procedure during which lung tumor tissue will be removed

Lung cancer
Blood samplePROCEDURE

Patients will be asked for a venous blood sample

Lung cancer

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

People who have or may have lung cancer.

You may qualify if:

  • Diagnosis of suspected lung cancer or lung cancer

You may not qualify if:

  • Inability to undergo therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Lung tumor tissue and blood samples will be collected.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

ImmunohistochemistryBlotting, WesternBlood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayMolecular Probe TechniquesSpecimen HandlingPuncturesSurgical Procedures, Operative

Study Officials

  • Christine Lovly, MD, PhD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine and Cancer Biology

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

December 1, 2005

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

US(1)