Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening (SPIT-LC)

Scottsdale Healthcare

Status: Terminated

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00607425

IASLC

2007-094

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

1

Description:

Non-small cell lung cancer patients

2

Description:

Healthy control subjects