NCT00897117

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer. PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started May 2001

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress83%
May 2001May 2031

Study Start

First participant enrolled

May 1, 2001

Completed
8 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
22.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2031

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

30.1 years

First QC Date

May 9, 2009

Last Update Submit

September 22, 2025

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Protein and RNA expression fingerprints from collected samples

    after collection of designated samples

Secondary Outcomes (2)

  • Development of statistical and computational methods to model relationship of data and clinical outcomes

    after laboratory gene analysis work is completed

  • Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival

    after collection of designated samples

Study Arms (1)

Resectable non-small cell lung cancer

Patients with clinical stage I or II invasive lung cancer that can be completely removed by surgery and who have not undergone chemotherapy or radiotherapy before surgery

Genetic: gene expression analysisGenetic: microarray analysisGenetic: protein expression analysisOther: biologic sample preservation procedureOther: laboratory biomarker analysisOther: matrix-assisted laser desorption/ionization time of flight mass spectrometry

Interventions

gene expression analysisGENETIC

Blood and lung tissue collection

Resectable non-small cell lung cancer
microarray analysisGENETIC

Blood and lung tissue collection

Resectable non-small cell lung cancer
protein expression analysisGENETIC

Blood and lung tissue collection

Resectable non-small cell lung cancer
biologic sample preservation procedureOTHER

Blood and lung tissue collection

Resectable non-small cell lung cancer
laboratory biomarker analysisOTHER

Blood and lung tissue collection

Resectable non-small cell lung cancer
matrix-assisted laser desorption/ionization time of flight mass spectrometryOTHER

Blood and lung tissue collection

Resectable non-small cell lung cancer

Eligibility Criteria

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

People who have clinical stage I and II non-small cell lung cancer

You may qualify if:

  • Diagnosis of non-small cell lung cancer
  • Clinical stage I and II disease
  • Resectable disease and complete surgical resection planned
  • Treated on companion studies at Vanderbilt University, the Veterans Administration hospital, St. Thomas, and Vanderbilt-Ingram Cancer Center Affiliate Network
  • Tumor specimen samples must be available at resection

You may not qualify if:

  • Chemotherapy before surgery
  • Radiotherapy before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dan Rudy Cancer Center at Saint Thomas Hospital

Nashville, Tennessee, 37205, United States

COMPLETED

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

SUSPENDED

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Both prospective and retrospectives samples of blood and tissue.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Gene Expression ProfilingMicroarray Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical Procedures

Study Officials

  • Eric Grogan, MD

    Vanderbilt Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

VICC Clinical Trials Information Program

CONTACT

800-811-8480cip@vumc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Thoracic Surgery

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2001

Primary Completion (Estimated)

May 31, 2031

Study Completion (Estimated)

May 31, 2031

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations

US(3)