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

This study has been terminated.
( Change in isolation method )

Sponsors and Collaborators: Scottsdale Healthcare
University of California, Los Angeles
University of Colorado at Denver and Health Sciences Center
Department of Veterans Affairs
University of Kansas
Information provided by: Scottsdale Healthcare
ClinicalTrials.gov Identifier: NCT00607425
  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

MedlinePlus related topics:   Cancer    Lung Cancer   

U.S. FDA Resources

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

Further study details as provided by Scottsdale Healthcare:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607425

Sponsors and Collaborators
Scottsdale Healthcare
University of California, Los Angeles
University of Colorado at Denver and Health Sciences Center
Department of Veterans Affairs
University of Kansas

Investigators
Principal Investigator:     Glen J Weiss, MD     TGen Clinical Research Services at Scottsdale Healthcare    
  More Information


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

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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Healthy
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 06, 2008




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