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Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01692951
Enrollment
220
Registered
2012-09-26
Start date
2012-08-31
Completion date
2014-09-30
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Biomarkers, Fatty Acids

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.

Interventions

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

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compare Concentration of Fatty Acids and Their MetabolitesAt the time of diagnosis, prior to the initiation of lung cancer treatmentBiochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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
37
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. 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
111
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. 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
18
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. 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
54
Total220

Baseline characteristics

CharacteristicControl Matched to Squamous CellTotalLung Adenocarcinoma PatientsControl Matched to AdenocarcinomaLung Squamous Cell Carcinoma Patients
Age, Continuous68 years
STANDARD_DEVIATION 6
66 years
STANDARD_DEVIATION 7
66 years
STANDARD_DEVIATION 11
65 years
STANDARD_DEVIATION 6
70 years
STANDARD_DEVIATION 9
Amount of Cigarette Smoking as Pack-year39 pack-year40 pack-year40 pack-year40 pack-year38 pack-year
COPD11 Participants58 Participants10 Participants32 Participants5 Participants
Family history of lung cancer16 Participants48 Participants6 Participants21 Participants5 Participants
Sex: Female, Male
Female
24 Participants84 Participants13 Participants40 Participants7 Participants
Sex: Female, Male
Male
30 Participants136 Participants24 Participants71 Participants11 Participants
Smoking status
Current
12 participants56 participants9 participants32 participants3 participants
Smoking status
Former
39 participants157 participants27 participants76 participants15 participants
Smoking status
Never
3 participants7 participants1 participants3 participants0 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 1110 / 180 / 54
other
Total, other adverse events
0 / 370 / 1110 / 180 / 54
serious
Total, serious adverse events
0 / 370 / 1110 / 180 / 54

Outcome results

Primary

Compare Concentration of Fatty Acids and Their Metabolites

Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.

Time frame: At the time of diagnosis, prior to the initiation of lung cancer treatment

ArmMeasureGroupValue (MEDIAN)
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesArachidonic Acid5.70 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites12-hydroxyeicosatetraenoic acid0.94 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesC16-lysophospholipid platelet activating factor0.0 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesHydroperoxyoctadecadienoyl phosphatidylcholine22.3 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites5-hydroxyeicosatetraenoic acid0.05 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites11-hydroxyeicosatetraenoic acid0.07 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesHydroxyoctadecadienoylphosphatidylcholine2.5 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesLinoleic Acid0.59 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites9-hydroxyoctadecadienoic acid0.56 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl platelet activating factor0.4 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl phosphatidylcholine0.2 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites15-hydroxyeicosatetraenoic acid0.02 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesC18-lysophospholipid platelet activating factor12.7 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites13-hydroxyoctadecadienoic acid0.43 mg/mL
Lung Adenocarcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesC16-lyso-phosphatidylcholine8.3 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesC16-lyso-phosphatidylcholine9.8 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their Metabolites12-hydroxyeicosatetraenoic acid0.23 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl platelet activating factor0.5 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesC16-lysophospholipid platelet activating factor0.0 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesLinoleic Acid0.34 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their Metabolites11-hydroxyeicosatetraenoic acid0.03 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their Metabolites15-hydroxyeicosatetraenoic acid0.01 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their Metabolites5-hydroxyeicosatetraenoic acid0.03 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesHydroperoxyoctadecadienoyl phosphatidylcholine17.9 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesC18-lysophospholipid platelet activating factor16.5 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their Metabolites13-hydroxyoctadecadienoic acid0.48 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their Metabolites9-hydroxyoctadecadienoic acid0.58 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl phosphatidylcholine0.2 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesHydroxyoctadecadienoylphosphatidylcholine7.1 mg/mL
Control Matched to AdenocarcinomaCompare Concentration of Fatty Acids and Their MetabolitesArachidonic Acid2.95 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesC16-lyso-phosphatidylcholine12 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesArachidonic Acid4.24 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesLinoleic Acid0.44 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesHydroperoxyoctadecadienoyl phosphatidylcholine18 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesHydroxyoctadecadienoylphosphatidylcholine4 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl platelet activating factor0.5 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl phosphatidylcholine0.2 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesC18-lysophospholipid platelet activating factor13 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their MetabolitesC16-lysophospholipid platelet activating factor0.0 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites5-hydroxyeicosatetraenoic acid0.04 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites11-hydroxyeicosatetraenoic acid0.04 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites12-hydroxyeicosatetraenoic acid0.42 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites15-hydroxyeicosatetraenoic acid0.01 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites9-hydroxyoctadecadienoic acid0.52 mg/mL
Lung Squamous Cell Carcinoma PatientsCompare Concentration of Fatty Acids and Their Metabolites13-hydroxyoctadecadienoic acid0.49 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesC18-lysophospholipid platelet activating factor17 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesLinoleic Acid0.32 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their Metabolites12-hydroxyeicosatetraenoic acid0.22 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl phosphatidylcholine0.2 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesAzelaoyl platelet activating factor0.5 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesArachidonic Acid3.18 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their Metabolites15-hydroxyeicosatetraenoic acid0.01 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesHydroxyoctadecadienoylphosphatidylcholine9 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesHydroperoxyoctadecadienoyl phosphatidylcholine18 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their Metabolites13-hydroxyoctadecadienoic acid0.44 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their Metabolites5-hydroxyeicosatetraenoic acid0.03 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesC16-lysophospholipid platelet activating factor0.1 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their Metabolites9-hydroxyoctadecadienoic acid0.51 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their Metabolites11-hydroxyeicosatetraenoic acid0.03 mg/mL
Control Matched to Squamous CellCompare Concentration of Fatty Acids and Their MetabolitesC16-lyso-phosphatidylcholine13 mg/mL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026