Tumor Markers in Lung Cancer

NCT ID: NCT01274468

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Gary Kinasewitz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary T Kinasewitz, MD

Role: PRINCIPAL_INVESTIGATOR

OU Health Sciences Center

Locations

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Veterans Affairs Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18480839 (View on PubMed)

Other Identifiers

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14781

Identifier Type: -

Identifier Source: org_study_id