Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

An observational study of Lung Cancer and Biomarkers, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Lung Cancer, Biomarkers, Fatty Acids
What is being tested?: serum sample
How many people: 220 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Sep 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patient samples are retrieved from the Cleveland Clinic Biobank.

Who may be able to join

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.

Who cannot join

Lung cancer patient without serum sample before the initiation of treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

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

Read the 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.

Conditions: Lung Cancer, Biomarkers, Fatty Acids
Being tested: serum sample
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

serum sampleOther
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

Study groups in NCT01692951
Study group	Role	What they receive
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. Receives: Other: serum sample
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. Receives: Other: serum sample
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. Receives: Other: serum sample
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. Receives: Other: serum sample

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At the time of diagnosis, prior to the initiation of lung cancer treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Sep 2014

First posted26 Sep 2012 (estimated)
Study startAug 2012
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01692951
Sponsor's protocol ID: 12-306
Status last verified: Apr 2017
First submitted: 21 Sep 2012
Last updated: 20 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
ClinicalTrials.gov ID: NCT01692951
Acronym / sponsor ID: 12-306
Conditions: Lung Cancer, Biomarkers, Fatty Acids
Study type: Observational
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: Aug 2012 (actual)
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 26 Sep 2012 (estimated)
Results: Posted 20 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Lung adenocarcinoma patients	–	Other: serum sampleSerum 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 adenocarcinoma	–	Other: serum sampleControl 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.
Lung squamous cell carcinoma patients	–	Other: serum sampleSerum 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.
Control matched to squamous cell	–	Other: serum sampleControl 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.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patient samples are retrieved from the Cleveland Clinic Biobank.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

Lung cancer patient without serum sample before the initiation of treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
serum sampleSerum 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	Other	Control matched to adenocarcinoma, Control matched to squamous cell, Lung adenocarcinoma patients, Lung squamous cell carcinoma patients

Primary outcome

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.

Results and safety

Results posted to the registry on 20 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lung Adenocarcinoma Patients	37	37
Control Matched to Adenocarcinoma	111	111
Lung Squamous Cell Carcinoma Patients	18	18
Control Matched to Squamous Cell	54	54

Primary outcome: Compare Concentration of Fatty Acids and Their Metabolites

Time frame: At the time of diagnosis, prior to the initiation of lung cancer treatment. Median (Inter-Quartile Range). Unit: mg/mL

Measure	Lung Adenocarcinoma Patients n = 37	Control Matched to Adenocarcinoma n = 111	Lung Squamous Cell Carcinoma Patients n = 18	Control Matched to Squamous Cell n = 54
Arachidonic Acid	5.70 (4.62 to 7.74)	2.95 (2.26 to 4.63)	4.24 (3.65 to 5.05)	3.18 (2.43 to 4.45)
Linoleic Acid	0.59 (0.46 to 0.73)	0.34 (0.22 to 0.52)	0.44 (0.33 to 0.64)	0.32 (0.23 to 0.42)
Hydroperoxyoctadecadienoyl phosphatidylcholine	22.3 (13.1 to 33.3)	17.9 (12.3 to 23.6)	18 (16 to 29)	18 (14 to 24)
Hydroxyoctadecadienoylphosphatidylcholine	2.5 (1.9 to 5.5)	7.1 (3.2 to 13.1)	4 (2 to 18)	9 (4 to 16)
Azelaoyl platelet activating factor	0.4 (0.3 to 0.5)	0.5 (0.3 to 0.8)	0.5 (0.3 to 0.8)	0.5 (0.3 to 0.8)
Azelaoyl phosphatidylcholine	0.2 (0.2 to 0.3)	0.2 (0.2 to 0.3)	0.2 (0.2 to 0.3)	0.2 (0.2 to 0.2)
C18-lysophospholipid platelet activating factor	12.7 (8.6 to 15.7)	16.5 (13.1 to 19.8)	13 (11 to 14)	17 (13 to 20)
C16-lyso-phosphatidylcholine	8.3 (6.2 to 17.8)	9.8 (6.6 to 30.6)	12 (6 to 52)	13 (7 to 42)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lung Adenocarcinoma Patients	0 of 37 (0%)	0 of 37 (0%)	0 of 37
Control Matched to Adenocarcinoma	0 of 111 (0%)	0 of 111 (0%)	0 of 111
Lung Squamous Cell Carcinoma Patients	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Control Matched to Squamous Cell	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lung Cancer

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Sessler, M.D. principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Biomarkers, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare Concentration of Fatty Acids and Their Metabolites (time frame: At the time of diagnosis, prior to the initiation of lung cancer treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01692951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.