Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01692951
Collaborator
(none)
220
1
25
8.8
Study Details
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 | Phase |
|---|---|---|
|
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
:
Aug 1, 2012
Actual Primary Completion Date
:
Sep 1, 2014
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | 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
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Daniel Sessler, M.D., The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
d sessler,
MD,
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01692951
Other Study ID Numbers:
- 12-306
First Posted:
Sep 26, 2012
Last Update Posted:
Jun 20, 2017
Last Verified:
Apr 1, 2017
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lung Adenocarcinoma Patients | Control Matched to Adenocarcinoma | Lung Squamous Cell Carcinoma Patients | Control Matched to Squamous Cell |
|---|---|---|---|---|
| Arm/Group Description | 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 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 | 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 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 |
| Period Title: Overall Study | ||||
| STARTED | 37 | 111 | 18 | 54 |
| COMPLETED | 37 | 111 | 18 | 54 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Lung Adenocarcinoma Patients | Control Matched to Adenocarcinoma | Lung Squamous Cell Carcinoma Patients | Control Matched to Squamous Cell | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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 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 | 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 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 of all reporting groups |
| Overall Participants | 37 | 111 | 18 | 54 | 220 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
66
(11)
|
65
(6)
|
70
(9)
|
68
(6)
|
66
(7)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
13
35.1%
|
40
36%
|
7
38.9%
|
24
44.4%
|
84
38.2%
|
| Male |
24
64.9%
|
71
64%
|
11
61.1%
|
30
55.6%
|
136
61.8%
|
| Smoking status (participants) [Number] | |||||
| Never |
1
2.7%
|
3
2.7%
|
0
0%
|
3
5.6%
|
7
3.2%
|
| Former |
27
73%
|
76
68.5%
|
15
83.3%
|
39
72.2%
|
157
71.4%
|
| Current |
9
24.3%
|
32
28.8%
|
3
16.7%
|
12
22.2%
|
56
25.5%
|
| Family history of lung cancer (Count of Participants) | |||||
| Count of Participants [Participants] |
6
16.2%
|
21
18.9%
|
5
27.8%
|
16
29.6%
|
48
21.8%
|
| COPD (Count of Participants) | |||||
| Count of Participants [Participants] |
10
27%
|
32
28.8%
|
5
27.8%
|
11
20.4%
|
58
26.4%
|
| Amount of Cigarette Smoking as Pack-year (pack-year) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [pack-year] |
40
|
40
|
38
|
39
|
40
|
Outcome Measures
| Title | Compare Concentration of Fatty Acids and Their Metabolites |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lung Adenocarcinoma Patients | Control Matched to Adenocarcinoma | Lung Squamous Cell Carcinoma Patients | Control Matched to Squamous Cell |
|---|---|---|---|---|
| Arm/Group Description | 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 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 | 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 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 |
| Measure Participants | 37 | 111 | 18 | 54 |
| Arachidonic Acid |
5.70
|
2.95
|
4.24
|
3.18
|
| Linoleic Acid |
0.59
|
0.34
|
0.44
|
0.32
|
| Hydroperoxyoctadecadienoyl phosphatidylcholine |
22.3
|
17.9
|
18
|
18
|
| Hydroxyoctadecadienoylphosphatidylcholine |
2.5
|
7.1
|
4
|
9
|
| Azelaoyl platelet activating factor |
0.4
|
0.5
|
0.5
|
0.5
|
| Azelaoyl phosphatidylcholine |
0.2
|
0.2
|
0.2
|
0.2
|
| C18-lysophospholipid platelet activating factor |
12.7
|
16.5
|
13
|
17
|
| C16-lyso-phosphatidylcholine |
8.3
|
9.8
|
12
|
13
|
| C16-lysophospholipid platelet activating factor |
0.0
|
0.0
|
0.0
|
0.1
|
| 5-hydroxyeicosatetraenoic acid |
0.05
|
0.03
|
0.04
|
0.03
|
| 11-hydroxyeicosatetraenoic acid |
0.07
|
0.03
|
0.04
|
0.03
|
| 12-hydroxyeicosatetraenoic acid |
0.94
|
0.23
|
0.42
|
0.22
|
| 15-hydroxyeicosatetraenoic acid |
0.02
|
0.01
|
0.01
|
0.01
|
| 9-hydroxyoctadecadienoic acid |
0.56
|
0.58
|
0.52
|
0.51
|
| 13-hydroxyoctadecadienoic acid |
0.43
|
0.48
|
0.49
|
0.44
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Lung Adenocarcinoma Patients | Control Matched to Adenocarcinoma | Lung Squamous Cell Carcinoma Patients | Control Matched to Squamous Cell | ||||
| Arm/Group Description | 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 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 | 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 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 | ||||
All Cause Mortality |
||||||||
| Lung Adenocarcinoma Patients | Control Matched to Adenocarcinoma | Lung Squamous Cell Carcinoma Patients | Control Matched to Squamous Cell | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | 0/111 (0%) | 0/18 (0%) | 0/54 (0%) | ||||
Serious Adverse Events |
||||||||
| Lung Adenocarcinoma Patients | Control Matched to Adenocarcinoma | Lung Squamous Cell Carcinoma Patients | Control Matched to Squamous Cell | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | 0/111 (0%) | 0/18 (0%) | 0/54 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Lung Adenocarcinoma Patients | Control Matched to Adenocarcinoma | Lung Squamous Cell Carcinoma Patients | Control Matched to Squamous Cell | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | 0/111 (0%) | 0/18 (0%) | 0/54 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Daniel Sessler, MD |
|---|---|
| Organization | Cleveland Clinic Foundation |
| Phone | 216-444-4900 |
| sessled@ccf.org |
Responsible Party:
d sessler,
MD,
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01692951
Other Study ID Numbers:
- 12-306
First Posted:
Sep 26, 2012
Last Update Posted:
Jun 20, 2017
Last Verified:
Apr 1, 2017