Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening (SPIT-LC)
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ClinicalTrials.gov Identifier: NCT00607425 |
Recruitment Status :
Terminated
(Change in isolation method)
First Posted : February 5, 2008
Last Update Posted : July 17, 2008
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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 |
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Non-Small Cell Lung Cancer |
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 |

Group/Cohort |
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1
Non-small cell lung cancer patients
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2
Healthy control subjects
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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.
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 |
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:
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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).
- Adults age 40-79
- Ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and FDA guidelines
Exclusion Criteria:
- No active pulmonary infection, i.e. bronchitis or pneumonia for 6 months
- No use of steroid inhalers for > 6 months
- 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

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
Principal Investigator: | Glen J Weiss, MD | TGen Clinical Research Services at Scottsdale Healthcare |
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 |
non-small cell lung cancer screening saliva gene expression healthy control subject |
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 |