NCT00898209

Brief Summary

RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with cancer and from healthy participants to study 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 collecting and analyzing samples of blood and exhaled breath from patients who have or are at high risk for lung cancer and from healthy participants.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
564

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Status
terminated

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 1, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3 months 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 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 24, 2014

Status Verified

April 1, 2013

Enrollment Period

5.8 years

First QC Date

May 9, 2009

Last Update Submit

June 23, 2014

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Ability of proteomic patterns to detect and discriminate lung cancer

    Serum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer

    Once at study entry

  • Correlation of proteomic patterns with tumor behavior

    Once at study entry

Study Arms (2)

Health Volunteers

Blood and exhaled breath condensate will be collected.

Genetic: protein expression analysisGenetic: proteomic profilingOther: biologic sample preservation procedureOther: laboratory biomarker analysisOther: matrix-asst laser desorption/ionization time flight mass spectrometryOther: questionnaire administration

Patients at risk or already identified as having lung cancer

Blood and exhaled breath condensate will be collected.

Genetic: protein expression analysisGenetic: proteomic profilingOther: biologic sample preservation procedureOther: laboratory biomarker analysisOther: matrix-asst laser desorption/ionization time flight mass spectrometryOther: questionnaire administration

Interventions

protein expression analysisGENETIC

Blood and exhaled breath condensate will be collected.

Health VolunteersPatients at risk or already identified as having lung cancer
proteomic profilingGENETIC

Blood and exhaled breath condensate will be collected.

Health VolunteersPatients at risk or already identified as having lung cancer
biologic sample preservation procedureOTHER

Blood and exhaled breath condensate will be collected.

Health VolunteersPatients at risk or already identified as having lung cancer
laboratory biomarker analysisOTHER

Blood and exhaled breath condensate will be collected.

Health VolunteersPatients at risk or already identified as having lung cancer
matrix-asst laser desorption/ionization time flight mass spectrometryOTHER

Blood and exhaled breath condensate will be collected.

Health VolunteersPatients at risk or already identified as having lung cancer
questionnaire administrationOTHER

Questionnaire will be completed.

Health VolunteersPatients at risk or already identified as having lung cancer

Eligibility Criteria

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

Healthy volunteers as well as patients at risk or already identified as having lung cancer.

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Normal healthy volunteer * At high risk for lung cancer (e.g., \> 30-pack year history of smoking; chronic obstructive pulmonary disease; or disease-free after surgical resection of lung cancer) * Diagnosis of stage I, II, IIIA, IIIB, or IV lung cancer * Must be willing to allow blood and exhaled breath condensate samples to be stored for genetic testing PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood lymphocyte DNA, and Exhaled breath condensate

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

  • Pierre P. Massion, MD

    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
Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2003

Primary Completion

February 1, 2009

Study Completion

December 1, 2009

Last Updated

June 24, 2014

Record last verified: 2013-04