Tumor Markers in Lung Cancer: DCAMLK-1LK-1
Primary Purpose
Lung Cancer, Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Measure DCAM levels in blood
DCAM levels in blood
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, smoking
Eligibility Criteria
Inclusion Criteria:
- >45 years of age
Exclusion Criteria:
- Unable to provide informed consent
Sites / Locations
- VAMC-OKC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lung Cancer
Lung Disease
Arm Description
Diagnostic
Diagnostic
Outcomes
Primary Outcome Measures
Tumor Markers in Lung Cancer:
DCAMLK-1LK-1 levels will be measured in the blood of patients with Lung Cancer and compared to that of controls with other lung diseases.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01578018
Brief Title
Tumor Markers in Lung Cancer: DCAMLK-1LK-1
Official Title
Tumor Markers in Lung Cancer: DCAMLK-1LK-1: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung cancers.
The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking status.
Detailed Description
In the investigators' preliminary study DCAMKL1 antigen was detected not only in malignant tissue, but also in BAL fluid from patients with benign lung disease. This suggests that DCAMKL1 expression might be induced by smoking or benign lung diseases. To examine this hypothesis, the investigators will compare DCAMLK1 expression in blood from patients with lung cancer to controls who are current or former smokers with benign lung disease.
Previous work has showed that DCAMLK1 is not detectable in the blood of healthy non smoking individuals. To determine whether smoking and or pulmonary inflammation induce DCAMLK1 expression, the investigators will obtain serum samples from 20 control patients with lung disease who are seen in the Chest Clinic at the Oklahoma City VAMC. Smoking histories will be obtained for all participants and DCAMLK1 levels will be correlated with smoking status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Smoking
Keywords
lung cancer, smoking
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung Cancer
Arm Type
Other
Arm Description
Diagnostic
Arm Title
Lung Disease
Arm Type
Other
Arm Description
Diagnostic
Intervention Type
Other
Intervention Name(s)
Measure DCAM levels in blood
Other Intervention Name(s)
Lung Cancer
Intervention Description
Measure DCAM levels in blood
Intervention Type
Other
Intervention Name(s)
DCAM levels in blood
Other Intervention Name(s)
Lung Disease
Intervention Description
DCAM levels in blood
Primary Outcome Measure Information:
Title
Tumor Markers in Lung Cancer:
Description
DCAMLK-1LK-1 levels will be measured in the blood of patients with Lung Cancer and compared to that of controls with other lung diseases.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>45 years of age
Exclusion Criteria:
Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kellie Jones, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
VAMC-OKC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tumor Markers in Lung Cancer: DCAMLK-1LK-1
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