Tumor Markers in Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01274468
First received: May 20, 2010
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tumor Markers in Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Identification of DCAMLK1 in BAL and lung biopsy specimens. [ Time Frame: After collection and analysis of specimens. ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Lung biopsy


Enrollment: 10
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ten patients with an expected age >45 years

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274468

Locations
United States, Oklahoma
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Gary T Kinasewitz, MD OU Health Sciences Center
  More Information

Publications:
Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01274468     History of Changes
Other Study ID Numbers: 14781
Study First Received: May 20, 2010
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014