Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

Completed

• Conditions: Biomarkers; Lung Cancer; Fatty Acids
• Interventions: Other: serum sample

• Registration Number: NCT01692951
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-26
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2017-02-21
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Results First Posted: 2017-06-20
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung squamous cell carcinoma patients	serum sample	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.
Lung adenocarcinoma patients	serum sample	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.
Control matched to squamous cell	serum sample	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.
Control matched to adenocarcinoma	serum sample	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.

Primary Outcome Measures

Name	Time	Method
Compare Concentration of Fatty Acids and Their Metabolites	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States