Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 3:18 AM
Study NCT ID:
NCT01274468
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2010-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Markers in Lung Cancer
Sponsor:
University of Oklahoma
Organization:
Study Overview
Official Title:
Tumor Markers in Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer.
Detailed Description:
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, we speculate that DCAMLK1 will also be upregulated in lung cancers. The aim of this pilot study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer.
This is a prospective study in 10 patients with lung masses suspected to be malignant who are scheduled for diagnostic bronchoscopy.
Patients with lung masses scheduled for diagnostic bronchoscopy will be included if they can give informed consent to participate and the diagnostic portion of the bronchoscopy has been uncomplicated. Patients considered to be at high risk during bronchoscopy because of either abnormal blood gases (Pco2 \> 50 mmHg or PaO2 \< 70 mmHg on oxygen) or coagulopathy (platelets \<100,000 or INR \> 1.5) will be excluded.
If the preliminary results indicate this is feasible, we will then propose a larger study to examine DCAMLK1 distribution in normal and cancerous tissue as well as the predictive value of this biomarker.
This is a prospective study in 10 patients with lung masses suspected to be malignant who are scheduled for diagnostic bronchoscopy.
Patients with lung masses scheduled for diagnostic bronchoscopy will be included if they can give informed consent to participate and the diagnostic portion of the bronchoscopy has been uncomplicated. Patients considered to be at high risk during bronchoscopy because of either abnormal blood gases (Pco2 \> 50 mmHg or PaO2 \< 70 mmHg on oxygen) or coagulopathy (platelets \<100,000 or INR \> 1.5) will be excluded.
If the preliminary results indicate this is feasible, we will then propose a larger study to examine DCAMLK1 distribution in normal and cancerous tissue as well as the predictive value of this biomarker.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: