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Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
d sessler, Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01692951
First received: September 21, 2012
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.

Condition Intervention
Lung Cancer Biomarkers Fatty Acids Other: serum sample

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

Resource links provided by NLM:


Further study details as provided by d sessler, Outcomes Research Consortium:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
Blood will be sampled for FFA metabolites

Enrollment: 220
Actual Study Start Date: August 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient samples are retrieved from the Cleveland Clinic Biobank.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692951

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Daniel Sessler, M.D. The Cleveland Clinic
  More Information

Responsible Party: d sessler, MD, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT01692951     History of Changes
Other Study ID Numbers: 12-306
Study First Received: September 21, 2012
Results First Received: February 21, 2017
Last Updated: April 6, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 19, 2017