Lung CancerNCT01578018
Tumor Markers in Lung Cancer: DCAMLK-1LK-1
A study testing Measure DCAM levels in blood and DCAM levels in blood in people with Lung Cancer and Smoking, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Smoking
- What is being tested?
- Measure DCAM levels in blood and DCAM levels in blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >45 years of age
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tumor Markers in Lung Cancer: DCAMLK-1LK-1: A Pilot Study
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.
Read the detailed description
In the investigators' preliminary study DCAMKL1 antigen was detected not only in malignant tissue, but also in BAL fluid from patients with benign lung disease. This suggests that DCAMKL1 expression might be induced by smoking or benign lung diseases. To examine this hypothesis, the investigators will compare DCAMLK1 expression in blood from patients with lung cancer to controls who are current or former smokers with benign lung disease.
Previous work has showed that DCAMLK1 is not detectable in the blood of healthy non smoking individuals. To determine whether smoking and or pulmonary inflammation induce DCAMLK1 expression, the investigators will obtain serum samples from 20 control patients with lung disease who are seen in the Chest Clinic at the Oklahoma City VAMC. Smoking histories will be obtained for all participants and DCAMLK1 levels will be correlated with smoking status.
- Conditions
- Lung Cancer, Smoking
- Being tested
- Measure DCAM levels in blood, DCAM levels in blood
- Keywords
- lung cancer, smoking
- Medical subject headings
- Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure DCAM levels in bloodOther
Also called Lung Cancer
Measure DCAM levels in blood
DCAM levels in bloodOther
Also called Lung Disease
DCAM levels in blood
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer | Other | Diagnostic Receives: Other: Measure DCAM levels in blood |
| Lung Disease | Other | Diagnostic Receives: Other: DCAM levels in blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Kinasewitz, University of Oklahoma
- Investigators
- Kellie Jones, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578018
- Sponsor's protocol ID
- 16249
- Status last verified
- Aug 2012
- First submitted
- 11 Apr 2012
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Markers in Lung Cancer: DCAMLK-1LK-1: A Pilot Study
- ClinicalTrials.gov ID
- NCT01578018
- Acronym / sponsor ID
- 16249
- Conditions
- Lung Cancer, Smoking
- Keywords
- lung cancer, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the investigators' preliminary study DCAMKL1 antigen was detected not only in malignant tissue, but also in BAL fluid from patients with benign lung disease. This suggests that DCAMKL1 expression might be induced by smoking or benign lung diseases. To examine this hypothesis, the investigators will compare DCAMLK1 expression in blood from patients with lung cancer to controls who are current or former smokers with benign lung disease.
Previous work has showed that DCAMLK1 is not detectable in the blood of healthy non smoking individuals. To determine whether smoking and or pulmonary inflammation induce DCAMLK1 expression, the investigators will obtain serum samples from 20 control patients with lung disease who are seen in the Chest Clinic at the Oklahoma City VAMC. Smoking histories will be obtained for all participants and DCAMLK1 levels will be correlated with smoking status.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer | Other | Other: Measure DCAM levels in bloodDiagnostic |
| Lung Disease | Other | Other: DCAM levels in bloodDiagnostic |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >45 years of age
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure DCAM levels in bloodAlso: Lung CancerMeasure DCAM levels in blood | Other | Lung Cancer |
| DCAM levels in bloodAlso: Lung DiseaseDCAM levels in blood | Other | Lung Disease |
Primary outcome
Tumor Markers in Lung Cancer:
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kellie Jones, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure DCAM levels in blood and DCAM levels in blood in people with Lung Cancer and Smoking, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Markers in Lung Cancer: (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.