Collecting and Analyzing Tissue Samples From Patients Und... | NCT00897117

Studies
Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer

NCT00897117

Sponsor

Vanderbilt-Ingram Cancer Center

Status

Recruiting

Last Update Posted

Sep 26, 2025Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

gene expression analysis
microarray analysis
protein expression analysis
biologic sample preservation procedure
laboratory biomarker analysis
matrix-assisted laser desorption/ionization time of flight mass spectrometry

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
P50CA090949	U.S. NIH Grant/Contract		View source
VU-VICC-THO-0136	Other Identifier	VICC
P30CA068485	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2001

Primary Completion Date

May 31, 2031Estimated

Completion Date

May 31, 2031Estimated

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eric Grogan, Associate Professor of Thoracic Surgery, Vanderbilt-Ingram Cancer CenterPrincipal Investigator

Lead Sponsor

Vanderbilt-Ingram Cancer CenterOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

OBJECTIVES:

Develop statistical and computational methods for modeling the relationships between multiple variable protein and RNA expression data and clinical endpoints using both supervised and unsupervised classification and pattern recognition approaches.
Determine protein and RNA expression fingerprints on completely resected non-small cell lung cancer without prior chemotherapy.
Correlate protein and RNA expression fingerprints with T-stage and nodal involvement at the time of surgery, and collect outcome data to allow correlation with recurrence (local and/or distant) and survival.

OUTLINE: This is a multicenter study.

Any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. Tissue are analyzed for molecular features that predict biologic behavior. Quantitation of RNA, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis.

Medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. Further progress in cancer treatment and tumor behavior after surgery are followed via record review.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 analysis Genetic: microarray analysis Genetic: protein expression analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gene expression analysis	Genetic	Blood and lung tissue collection	Resectable non-small cell lung cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Protein and RNA expression fingerprints from collected samples		after collection of designated samples

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

Chemotherapy before surgery
Radiotherapy before surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
VICC Clinical Trials Information Program	Contact	800-811-8480		cip@vumc.org

Overall Officials

Name	Affiliation	Role
Eric Grogan, MD	Vanderbilt Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dan Rudy Cancer Center at Saint Thomas Hospital	Completed	Nashville	Tennessee	37205	United States

References Module

Citations

Not provided

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms

ID	Term
D020869	Gene Expression Profiling
D046228	Microarray Analysis

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D046208	Microchip Analytical Procedures