NCT02406053

Brief Summary

The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory cells exert substantial pathological effects on the lung cells \[1\]. Oxidative stress (OS) is a major factor that plays a significant role in lung cancer (LC) \[2\], chronic obstructive pulmonary disease (COPD) \[3\] and obstructive sleep apnea syndrome (OSAS) \[4, 5\]. The current evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and progression of respiratory diseases. The major exposures that cause OS can be summarized as smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic diameter of 2.5 µm \[6-8\]. Epidemiological and clinical studies showed that the overall outcome of pulmonary OS is increased mortality due to increased incidence of respiratory diseases \[9\].

Trial Health

100
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

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

April 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

March 16, 2015

Last Update Submit

March 27, 2015

Conditions

Keywords

lung cancerantioxidantsoxidative damage

Outcome Measures

Primary Outcomes (1)

  • Oxidative damage by evaluating the oxidative and antioxidant biomarkers

    This study aimed to evaluate the oxidative damage in these diseases by evaluating the oxidative and antioxidant biomarkers

    4 months

Study Arms (4)

OSAS

Obstructive sleep apnea syndrome

Genetic: oxidative and antioxidant biomarkers

COPD

Chronic obstructive pulmonary disease

Genetic: oxidative and antioxidant biomarkers

LC

Lung cancer

Genetic: oxidative and antioxidant biomarkers

HC

Healthy controls

Genetic: oxidative and antioxidant biomarkers

Interventions

the oxidative damage in these diseases by evaluating the oxidative and antioxidant biomarkers.

COPDHCLCOSAS

Eligibility Criteria

Age38 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 111 participants (35 females, 76 males) with OSAS (n=29), COPD (n=26) and LC (n=28), and healthy controls (n=28) were included in the study.

You may qualify if:

  • Malondialdehyde (MDA), 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-OHdG), and coenzyme Q10 (CoQ10) levels were evaluated in the blood samples of patients with COPD, LC, and OSAS by high-pressure liquid chromatography method.

You may not qualify if:

  • The diagnosis of lung cancer was based on the analysis of biopsy or cytologic specimens obtained by bronchoscopic examination, transthoracic biopsy or surgery. The patients Who hadn't have chemo or/and radiotherapy were included to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sunnetcioglu A, Alp HH, Sertogullarindan B, Balaharoglu R, Gunbatar H. Evaluation of Oxidative Damage and Antioxidant Mechanisms in COPD, Lung Cancer, and Obstructive Sleep Apnea Syndrome. Respir Care. 2016 Feb;61(2):205-11. doi: 10.4187/respcare.04209. Epub 2015 Nov 24.

MeSH Terms

Conditions

Respiratory Tract DiseasesLung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Study Officials

  • AYSEL SUNNETCIOGLU, Phd

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Pulmory Diseas Aysel Sünnetçioğlu

Study Record Dates

First Submitted

March 16, 2015

First Posted

April 2, 2015

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

April 2, 2015

Record last verified: 2015-03