Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

Terminated

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00607425
• Lead Sponsor: Scottsdale Healthcare

Brief Summary

This is a pilot study to test the feasibility of using gene expression from saliva to identify patients with early-stage non-small cell lung cancer (NSCLC).

The primary objective of this study is to compare gene expression profiles from saliva from healthy controls and patients with early-stage non-small cell lung cancer.

To be eligible, patients with non-small cell lung cancer, must not yet have received treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). Health control participants may participate if they meet eligibility criteria listed below.

Eligible enrollees will be asked to submit a one time saliva sample and complete a study questionaire.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Last Update Submitted: 2008-07-15
• Last Update Posted: 2008-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with untreated stage I-II NSCLC OR Healthy control subjects: with a > 20 pack year history of cigarette smoking OR Never smokers (defined as less than 100 cigarettes over subject's lifetime)

   • The investigators recognize that pathologic confirmation is not always available prior to surgical resection of a lung mass. To account for this, subjects with a suspicious lung mass concerning for lung cancer, can be enrolled on this trial, and submit a saliva sample prior to surgical resection (ideally within 45 days of planned surgery).

2. Adults age 40-79

3. Ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and FDA guidelines

Exclusion Criteria

1. No active pulmonary infection, i.e. bronchitis or pneumonia for 6 months
2. No use of steroid inhalers for > 6 months
3. No other prior malignancy is allowed except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers from which the patient has been disease-free for 5 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified