NCT01692951

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 20, 2017

Completed
Last Updated

June 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

September 21, 2012

Results QC Date

February 21, 2017

Last Update Submit

April 6, 2017

Conditions

Lung CancerBiomarkersFatty Acids

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Study Arms (4)

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

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

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

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

Interventions

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

Control matched to adenocarcinomaControl matched to squamous cellLung adenocarcinoma patientsLung squamous cell carcinoma patients

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient samples are retrieved from the Cleveland Clinic Biobank.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Lung cancer patient without serum sample before the initiation of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be sampled for FFA metabolites

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Daniel Sessler, MD
Organization
Cleveland Clinic Foundation
sessled@ccf.org
216-444-4900

Study Officials

  • Daniel Sessler, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 26, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 20, 2017

Results First Posted

June 20, 2017

Record last verified: 2017-04

Locations

US(1)