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Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

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ClinicalTrials.gov Identifier: NCT01692951
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.

Condition or disease Intervention/treatment
Lung Cancer Biomarkers Fatty Acids Other: serum sample

Detailed Description:
We will compare the concentration of free fatty acids and their metabolites between patients with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy will be assessed for potential predictors.

Study Design

Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
Actual Study Start Date : August 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Lung adenocarcinoma patients
Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.
Other: serum sample
Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank
Control matched to adenocarcinoma
Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
Other: serum sample
Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank
Lung squamous cell carcinoma patients
Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.
Other: serum sample
Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank
Control matched to squamous cell
Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
Other: serum sample
Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank


Outcome Measures

Primary Outcome Measures :
  1. Compare Concentration of Fatty Acids and Their Metabolites [ Time Frame: At the time of diagnosis, prior to the initiation of lung cancer treatment ]
    Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.


Biospecimen Retention:   Samples Without DNA
Blood will be sampled for FFA metabolites

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient samples are retrieved from the Cleveland Clinic Biobank.
Criteria

Inclusion Criteria:

  • Age from 40 to 80
  • Lung adenocarcinoma with pathological diagnosis
  • Lung squamous cell carcinoma with pathological diagnosis
  • Control patients should have at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.

Exclusion Criteria:

- Lung cancer patient without serum sample before the initiation of treatment

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692951


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Daniel Sessler, M.D. The Cleveland Clinic
More Information

Responsible Party: d sessler, MD, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT01692951     History of Changes
Other Study ID Numbers: 12-306
First Posted: September 26, 2012    Key Record Dates
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017
Last Verified: April 2017

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