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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 )
Study NCT00607425   Information provided by Scottsdale Healthcare
First Received: January 22, 2008   Last Updated: July 15, 2008   History of Changes

January 22, 2008
July 15, 2008
August 2007
July 2008   (final data collection date for primary outcome measure)
 
To differentiate stage I-II NSCLC patients from healthy subjects by using the mRNA profile of cell-free supernatant from their unstimulated saliva [ Time Frame: 0 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00607425 on ClinicalTrials.gov Archive Site
 
To differentiate between smokers and never-smokers with stage I-II NSCLC patients from healthy current, former, or never-smokers by using the mRNA profile of cell-free supernatant from their unstimulated saliva [ Time Frame: 0 ] [ Designated as safety issue: No ]
 
Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening
Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

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.

 
 
Observational
Case Control, Other
Non-Small Cell Lung Cancer
 
  • Non-small cell lung cancer patients
  • Healthy control subjects
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
40
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00607425
Glen J. Weiss, MD, TGen Clinical Research Services at Scottsdale Healthcare
2007-094, IASLC
Scottsdale Healthcare
  • University of California, Los Angeles
  • University of Colorado at Denver and Health Sciences Center
  • Department of Veterans Affairs
  • University of Kansas
Principal Investigator: Glen J Weiss, MD TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale Healthcare
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP