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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 22, 2008 | ||||
| Last Updated Date | July 15, 2008 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00607425 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening | ||||
| Official Title ICMJE | Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case Control, Other | ||||
| Condition ICMJE | Non-Small Cell Lung Cancer | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 79 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00607425 | ||||
| Responsible Party | Glen J. Weiss, MD, TGen Clinical Research Services at Scottsdale Healthcare | ||||
| Study ID Numbers ICMJE | 2007-094, IASLC | ||||
| Study Sponsor ICMJE | Scottsdale Healthcare | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Scottsdale Healthcare | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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