NCT01578018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

April 11, 2012

Last Update Submit

August 8, 2012

Conditions

Lung CancerSmoking

Keywords

lung cancersmoking

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Lung Cancer

OTHER

Diagnostic

Other: Measure DCAM levels in blood

Lung Disease

OTHER

Diagnostic

Other: DCAM levels in blood

Interventions

Measure DCAM levels in bloodOTHER

Measure DCAM levels in blood

Also known as: Lung Cancer
Lung Cancer
DCAM levels in bloodOTHER

DCAM levels in blood

Also known as: Lung Disease
Lung Disease

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>45 years of age

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VAMC-OKC

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSmoking

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Kellie Jones, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 16, 2012

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

US(1)