Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(Change in isolation method)
University of California, Los Angeles
University of Colorado, Denver
VA Office of Research and Development
University of Kansas
Information provided by:
Scottsdale Healthcare Identifier:
First received: January 22, 2008
Last updated: July 15, 2008
Last verified: July 2008

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.

Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

Resource links provided by NLM:

Further study details as provided by Scottsdale Healthcare:

Biospecimen Retention:   Samples With DNA

Enrollment: 40
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Non-small cell lung cancer patients
Healthy control subjects


Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Untreated, clinical stage I and II non-small cell lung cancer (NSCLC) patients and matching healthy control subjects will be recruited to participate in this study.

Untreated patients have not yet had either complete surgical removal of their lung cancer, any chemotherapy, or any radiation therapy to treat their lung cancer.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00607425

Sponsors and Collaborators
Scottsdale Healthcare
University of California, Los Angeles
University of Colorado, Denver
VA Office of Research and Development
University of Kansas
Principal Investigator: Glen J Weiss, MD TGen Clinical Research Services at Scottsdale Healthcare
  More Information

Responsible Party: Glen J. Weiss, MD, TGen Clinical Research Services at Scottsdale Healthcare Identifier: NCT00607425     History of Changes
Other Study ID Numbers: 2007-094
Study First Received: January 22, 2008
Last Updated: July 15, 2008

Keywords provided by Scottsdale Healthcare:
non-small cell lung cancer
gene expression
healthy control subject

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on April 28, 2017