Trial Outcomes & Findings for Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer (NCT NCT01692951)
NCT ID: NCT01692951
Last Updated: 2017-06-20
Results Overview
Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.
Recruitment status
COMPLETED
Target enrollment
220 participants
Primary outcome timeframe
At the time of diagnosis, prior to the initiation of lung cancer treatment
Results posted on
2017-06-20
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
111
|
18
|
54
|
|
Overall Study
COMPLETED
|
37
|
111
|
18
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
Baseline characteristics by cohort
| Measure |
Lung Adenocarcinoma Patients
n=37 Participants
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
|
Control Matched to Adenocarcinoma
n=111 Participants
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
|
Lung Squamous Cell Carcinoma Patients
n=18 Participants
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
|
Control Matched to Squamous Cell
n=54 Participants
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
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 11 • n=5 Participants
|
65 years
STANDARD_DEVIATION 6 • n=7 Participants
|
70 years
STANDARD_DEVIATION 9 • n=5 Participants
|
68 years
STANDARD_DEVIATION 6 • n=4 Participants
|
66 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Smoking status
Never
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Smoking status
Former
|
27 participants
n=5 Participants
|
76 participants
n=7 Participants
|
15 participants
n=5 Participants
|
39 participants
n=4 Participants
|
157 participants
n=21 Participants
|
|
Smoking status
Current
|
9 participants
n=5 Participants
|
32 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
56 participants
n=21 Participants
|
|
Family history of lung cancer
|
6 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
COPD
|
10 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Amount of Cigarette Smoking as Pack-year
|
40 pack-year
n=5 Participants
|
40 pack-year
n=7 Participants
|
38 pack-year
n=5 Participants
|
39 pack-year
n=4 Participants
|
40 pack-year
n=21 Participants
|
PRIMARY outcome
Timeframe: At 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.
Outcome measures
| Measure |
Lung Adenocarcinoma Patients
n=37 Participants
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
|
Control Matched to Adenocarcinoma
n=111 Participants
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
|
Lung Squamous Cell Carcinoma Patients
n=18 Participants
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
|
Control Matched to Squamous Cell
n=54 Participants
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
|
|---|---|---|---|---|
|
Compare Concentration of Fatty Acids and Their Metabolites
15-hydroxyeicosatetraenoic acid
|
0.02 mg/mL
Interval 0.01 to 0.02
|
0.01 mg/mL
Interval 0.0 to 0.01
|
0.01 mg/mL
Interval 0.01 to 0.02
|
0.01 mg/mL
Interval 0.01 to 0.01
|
|
Compare Concentration of Fatty Acids and Their Metabolites
9-hydroxyoctadecadienoic acid
|
0.56 mg/mL
Interval 0.3 to 0.97
|
0.58 mg/mL
Interval 0.32 to 0.87
|
0.52 mg/mL
Interval 0.36 to 0.68
|
0.51 mg/mL
Interval 0.34 to 0.76
|
|
Compare Concentration of Fatty Acids and Their Metabolites
13-hydroxyoctadecadienoic acid
|
0.43 mg/mL
Interval 0.27 to 0.62
|
0.48 mg/mL
Interval 0.3 to 0.69
|
0.49 mg/mL
Interval 0.38 to 0.73
|
0.44 mg/mL
Interval 0.33 to 0.63
|
|
Compare Concentration of Fatty Acids and Their Metabolites
Arachidonic Acid
|
5.70 mg/mL
Interval 4.62 to 7.74
|
2.95 mg/mL
Interval 2.26 to 4.63
|
4.24 mg/mL
Interval 3.65 to 5.05
|
3.18 mg/mL
Interval 2.43 to 4.45
|
|
Compare Concentration of Fatty Acids and Their Metabolites
Linoleic Acid
|
0.59 mg/mL
Interval 0.46 to 0.73
|
0.34 mg/mL
Interval 0.22 to 0.52
|
0.44 mg/mL
Interval 0.33 to 0.64
|
0.32 mg/mL
Interval 0.23 to 0.42
|
|
Compare Concentration of Fatty Acids and Their Metabolites
Hydroperoxyoctadecadienoyl phosphatidylcholine
|
22.3 mg/mL
Interval 13.1 to 33.3
|
17.9 mg/mL
Interval 12.3 to 23.6
|
18 mg/mL
Interval 16.0 to 29.0
|
18 mg/mL
Interval 14.0 to 24.0
|
|
Compare Concentration of Fatty Acids and Their Metabolites
Hydroxyoctadecadienoylphosphatidylcholine
|
2.5 mg/mL
Interval 1.9 to 5.5
|
7.1 mg/mL
Interval 3.2 to 13.1
|
4 mg/mL
Interval 2.0 to 18.0
|
9 mg/mL
Interval 4.0 to 16.0
|
|
Compare Concentration of Fatty Acids and Their Metabolites
Azelaoyl platelet activating factor
|
0.4 mg/mL
Interval 0.3 to 0.5
|
0.5 mg/mL
Interval 0.3 to 0.8
|
0.5 mg/mL
Interval 0.3 to 0.8
|
0.5 mg/mL
Interval 0.3 to 0.8
|
|
Compare Concentration of Fatty Acids and Their Metabolites
Azelaoyl phosphatidylcholine
|
0.2 mg/mL
Interval 0.2 to 0.3
|
0.2 mg/mL
Interval 0.2 to 0.3
|
0.2 mg/mL
Interval 0.2 to 0.3
|
0.2 mg/mL
Interval 0.2 to 0.2
|
|
Compare Concentration of Fatty Acids and Their Metabolites
C18-lysophospholipid platelet activating factor
|
12.7 mg/mL
Interval 8.6 to 15.7
|
16.5 mg/mL
Interval 13.1 to 19.8
|
13 mg/mL
Interval 11.0 to 14.0
|
17 mg/mL
Interval 13.0 to 20.0
|
|
Compare Concentration of Fatty Acids and Their Metabolites
C16-lyso-phosphatidylcholine
|
8.3 mg/mL
Interval 6.2 to 17.8
|
9.8 mg/mL
Interval 6.6 to 30.6
|
12 mg/mL
Interval 6.0 to 52.0
|
13 mg/mL
Interval 7.0 to 42.0
|
|
Compare Concentration of Fatty Acids and Their Metabolites
C16-lysophospholipid platelet activating factor
|
0.0 mg/mL
Interval 0.0 to 0.0
|
0.0 mg/mL
Interval 0.0 to 0.1
|
0.0 mg/mL
Interval 0.0 to 0.1
|
0.1 mg/mL
Interval 0.0 to 0.1
|
|
Compare Concentration of Fatty Acids and Their Metabolites
5-hydroxyeicosatetraenoic acid
|
0.05 mg/mL
Interval 0.04 to 0.07
|
0.03 mg/mL
Interval 0.02 to 0.05
|
0.04 mg/mL
Interval 0.03 to 0.05
|
0.03 mg/mL
Interval 0.02 to 0.04
|
|
Compare Concentration of Fatty Acids and Their Metabolites
11-hydroxyeicosatetraenoic acid
|
0.07 mg/mL
Interval 0.03 to 0.11
|
0.03 mg/mL
Interval 0.02 to 0.05
|
0.04 mg/mL
Interval 0.04 to 0.06
|
0.03 mg/mL
Interval 0.02 to 0.04
|
|
Compare Concentration of Fatty Acids and Their Metabolites
12-hydroxyeicosatetraenoic acid
|
0.94 mg/mL
Interval 0.44 to 1.73
|
0.23 mg/mL
Interval 0.13 to 0.57
|
0.42 mg/mL
Interval 0.18 to 0.95
|
0.22 mg/mL
Interval 0.13 to 0.51
|
Adverse Events
Lung Adenocarcinoma Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Matched to Adenocarcinoma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lung Squamous Cell Carcinoma Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Matched to Squamous Cell
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place