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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607425
Recruitment Status : Terminated (Change in isolation method)
First Posted : February 5, 2008
Last Update Posted : July 17, 2008
Sponsor:
Collaborators:
University of California, Los Angeles
University of Colorado, Denver
US Department of Veterans Affairs
University of Kansas
Information provided by:
Scottsdale Healthcare

Study Description
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Brief Summary:

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 or disease
Non-Small Cell Lung Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Official Title: Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening
Study Start Date : August 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
Non-small cell lung cancer patients
2
Healthy control subjects


Outcome Measures
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Biospecimen Retention:   Samples With DNA
Saliva

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
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.

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607425


Sponsors and Collaborators
Scottsdale Healthcare
University of California, Los Angeles
University of Colorado, Denver
US Department of Veterans Affairs
University of Kansas
Investigators
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Principal Investigator: Glen J Weiss, MD TGen Clinical Research Services at Scottsdale Healthcare
More Information
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Responsible Party: Glen J. Weiss, MD, TGen Clinical Research Services at Scottsdale Healthcare
ClinicalTrials.gov Identifier: NCT00607425    
Other Study ID Numbers: 2007-094
IASLC
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: July 17, 2008
Last Verified: July 2008
Keywords provided by Scottsdale Healthcare:
non-small cell lung cancer
screening
saliva
gene expression
healthy control subject
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms