Study of Tissue Samples From Patients With Stage I Non-Sm... | NCT00990873

ID	Type	Description	Link
CALGB-150803
CDR0000649826	Registry Identifier	NCI Physician Data Query

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Oct 6, 2009

First Submission Date that Met QC Criteria

Oct 6, 2009

First Posted Date

Oct 7, 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

Jun 27, 2016

Last Update Posted Date

Jun 28, 2016Estimated

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 the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue samples from patients with stage I non-small cell lung cancer enrolled on research study CALGB-140202.

Detailed Description

OBJECTIVES:

Determine whether the 64-gene signature can accurately predict the prognosis for survival of patients with stage I non-small cell lung cancer (NSCLC).

OUTLINE: RNA is purified from tissue samples obtained by the CALGB Lung Cancer Study (CALGB-140202). The RNA samples are used for gene expression analysis using the 64-gene signature and an Affymetrix-HG_U133A array. Reverse-transcriptase PCR may also be performed on selected samples.

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival, defined as the time from surgery to death of any cause		Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Disease-free survival, defined as time from surgery to any recurrence (local or regional), second primary tumor, distant metastasis, or death of any cause		Up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Registration to CALGB 140202
Institutional Review Board (IRB) review and approval at the institutions where the laboratory work will be performed is required
Informed Consent: The CALGB does not require that a separate consent form be signed for this study
- The subject population to be studied in this protocol includes patients selected from CALGB 140202. All such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial.
- All samples to be studied were obtained and stored as part of CALGB 140202. The material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information. In no instance will the patient be contacted directly.
- There should be no physical, psychological, social or legal risks associated with this study. No invasive procedures are recommended or requested.
- All appropriate and necessary procedures will be utilized to maintain confidentiality. All patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens.
- This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated. It is likely however, that the information gained will substantially help similar patients in the future.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with stage I non-small cell lung cancer and previously enrolled on CALGB 140202.

Sampling Method

Probability Sample

Name	Type	Description	Arm Group Labels	Other Names
gene expression analysis	Genetic
microarray analysis	Genetic
reverse transcriptase-polymerase chain reaction	Genetic
laboratory biomarker analysis	Other

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
D020133	Reverse Transcriptase Polymerase Chain Reaction

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D046208	Microchip Analytical Procedures
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques