Tumor Markers in Lung Cancer

Lung Cancer Clinical Trial

Official title:

Tumor Markers in Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274468
• Other study ID #: 14781
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: August 8, 2012
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• abnormality on chest x-ray that requires diagnosis and physically capable of undergoing bronchoscopy

Exclusion Criteria:

• <45 years

• Patients with severe abnormalities in blood gases and/or a coagulopathy will be excluded.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Humphries A, Wright NA. Colonic crypt organization and tumorigenesis. Nat Rev Cancer. 2008 Jun;8(6):415-24. doi: 10.1038/nrc2392. Epub 2008 May 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of DCAMLK1 in BAL and lung biopsy specimens.		After collection and analysis of specimens.	Yes