Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

April 6, 2017 updated by: d sessler, The Cleveland Clinic
This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patient samples are retrieved from the Cleveland Clinic Biobank.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of diagnosis, prior to the initiation of lung cancer treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Daniel Sessler, M.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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