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

This study has been terminated.
(Change in isolation method)
Sponsor:
Collaborators:
University of California, Los Angeles
University of Colorado, Denver
University of Kansas
Information provided by:
Scottsdale Healthcare
ClinicalTrials.gov Identifier:
NCT00607425
First received: January 22, 2008
Last updated: July 15, 2008
Last verified: July 2008
  Purpose

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.


Condition
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

Saliva


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)
Groups/Cohorts
1
Non-small cell lung cancer patients
2
Healthy control subjects

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT00607425

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

No publications provided

Responsible Party: Glen J. Weiss, MD, TGen Clinical Research Services at Scottsdale Healthcare
ClinicalTrials.gov Identifier: NCT00607425     History of Changes
Other Study ID Numbers: 2007-094, IASLC
Study First Received: January 22, 2008
Last Updated: July 15, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014