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

Non-Small Cell Lung Cancer Clinical Trial

— SPIT-LC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00607425
• Other study ID #: 2007-094
• Secondary ID: IASLC
• Status: Terminated
• Phase: N/A
• First received: January 22, 2008
• Last updated: July 15, 2008
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Scottsdale Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Scottsdale Healthcare	University of California, Los Angeles, University of Colorado, Denver, University of Kansas Medical Center, VA Office of Research and Development