Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers
Tracking Information | |||||
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First Received Date ICMJE | May 9, 2009 | ||||
Last Updated Date | November 22, 2010 | ||||
Start Date ICMJE | December 2008 | ||||
Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Levels of cathepsin D [ Time Frame: At Routine Follow-Up ] [ Designated as safety issue: No ] Measure plasma CD levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry. |
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Original Primary Outcome Measures ICMJE |
Levels of cathepsin D [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00897234 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Levels of fatty acid synthase [ Designated as safety issue: No ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers | ||||
Official Title ICMJE | Plasma Quantification of Cathepsin D and FAS in Non-Small Cell Lung Cancer | ||||
Brief Summary | RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood samples from patients with non-small cell lung cancer and from healthy volunteers. |
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Detailed Description | OBJECTIVES:
OUTLINE: Blood samples are collected from patients and healthy volunteers to measure the levels of cathepsin D and fatty acid synthase by proteomic profiling and mass spectrometry. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | Retention: Samples With DNA Description: Blood sample collection, one 10 ml purple top EDTA tube, will be collected from each patient and control via venipuncture or from a central line. |
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Sampling Method | Probability Sample | ||||
Study Population | Subjects who have non-small cell lung cancer (NSCLC) will be recruited from the Masonic Cancer Center at the University of Minnesota. Controls will be non-smoking individuals, age matched to the NSCLC subjects recruited through advertising. Normal controls should not be regularly exposed to second hand smoke. |
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Condition ICMJE | Lung Cancer | ||||
Intervention ICMJE | Other: Mass Spectrometry
Levels of Cathepsin D (CD) and fatty acid synthase (FAS) will be measured using isobaric tag labeling coupled with mass spectrometry. RNA concentration will be measured using spectrophometer and purity will be analyzed. |
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Study Group/Cohort (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 84 | ||||
Completion Date | October 2010 | ||||
Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Non-Small Cell Lung Cancer Patients
Healthy volunteer
Exclusion Criteria:
Written consent must be given for both subjects and controls. |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00897234 | ||||
Other Study ID Numbers ICMJE | 2008NTLS094, 0809M47482 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Robert Arthur Kratzke, M.D., Masonic Cancer Center, University of Minnesota | ||||
Study Sponsor ICMJE | Masonic Cancer Center, University of Minnesota | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Masonic Cancer Center, University of Minnesota | ||||
Verification Date | November 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |