Paraoxanase Enzyme Activity in Patients With Pulmonary Diseases

Bronchoalveolar Lavage Liq To Distinguish Benign and Malignant Pulmonary Diseases

Lipid per oxidation final products and free oxygen radicals are thought as initiator role for developing of cancer in the body. Level of paraoxonase in the patients with cancer varies. In this research, the investigators investigated the contribution of level of serum and bronchoalveolar lavage paraoxonase in the differentiation of benign and malignant lung disease patients. This research includes the patients that are diagnosis of lung cancer (research group) and benign pulmonary disease (control group) participated by accepted fiberoptic bronchoscopy (FOB).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lipid per oxidation final products and free oxygen radicals are thought as initiator role for developing of cancer in the body. Level of paraoxonase in the patients with cancer varies. In this research, the investigators investigated the contribution of level of serum and bronchoalveolar lavage paraoxonase in the differentiation of benign and malignant lung disease patients. This research includes the patients that are diagnosis of lung cancer (research group) and benign pulmonary disease (control group) participated by accepted fiberoptic bronchoscopy (FOB).

Paraoxonase and Cancer Relations Oxidative stress is one of the important etiologic factor in carcinogenesis. Serum PON1 activity was found to be significantly lower in patients with lung cancer than healthy people by Elkiran and her friends et al. Also, gastroesophageal cancer, meningioma, high-grade glioma and ovarian epithelial was found to be significantly lower in tumour patients according to control groups in plasma. The relationship between serum PON1 level and the occurrence of cancer is still unknown. PON1 polymorphism has been reported to be related with an increased risk of occurrence of cancer in relation to environmental chemicals.

Reactive oxygen radicals can usually lead to tissue damage by attacking all cell components. Increased free oxygen radicals and oxidative stress which is formed in the body are one of the important risk factor in increasing various types of cancer. Lipid peroxidation's final products and scavenger system components are thought to have for a starter role in oncogenesis. Carcinogenic radicals that are liposoluble are formed as a result of lipid peroxidation and PON1 binds with radicals that are liposoluble. PON1 are thought to be capable to metabolize these radicals that are liposoluble. PON1 activity and oxidative stress has been suggested to be inversely related in serum and macrophages. Loss of paraoxonase protective effect may play a role in increasing the sensitivity to genomic damage which inflammatory oxidants and diets carcinogens caused .

Purpose of this research is to compare serum and bronchoalveolar lavage liqs PON contrasts between patients with lung cancer and the control group and to determine if the enzyme is lower in plasma and bronchoalveolar lavage liqs in case of malignant.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. There are not any medical contraindications for fiberoptic bronchoscopy (FOB) and bronchoalveolar lavage(BAL)
  2. Bronchoscopic symptom does not constitute an impediment status to performing.
  3. The following method has been obtained in accordance with FOB and BAL material.

Exclusion Criteria:

  1. The presence of a medical contraindication to FOB and BAL
  2. During FOB not detecting or not technically making the suitable segment bronchus for BAL
  3. Not to be duly provided BAL materials.

Inclusion criteria for the control(benign lung diseases) group;

  1. Have lung disease without malignancy
  2. The absence of addition disease
  3. The absence of medical contraindications for FOB and BAL
  4. The following method has been obtained in accordance with FOB and BAL material. Exclusion criteria for the control group;

1. Detection of a new addition disease or the presence of the addition disease 2. To have a medical contraindication to FOB or BAL 3. Not to be duly provided BAL materials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lung Malignancy

Fiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.

The samples (fine-needle aspiration biopsy and fine-needle aspiration cytology) were diagnosed by pathological examination.

Fiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.
Other: Lung bening Diseases
Fiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.
Fiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of Paraoxonase Serum and BAL Levels between malignant and benign lung diseases
Time Frame: 3 month

Paraoxonase Measurement:

Before bronchoscopy, 10 cc of blood were drawn from all patients via the cubital vein in sterile conditions. 16x100 mm Ayset tube was placed in two biochemistry tube. BAL material and a tube of blood sample were sent to The Microbiology Laboratory after the operation. The other one was sent to The Biochemistry Laboratory.

Whole blood and BAL samples were centrifuged at 3500 rpm for 5 minutes in the laboratory and stocked at -200°C until the test run. Serum total cholesterol, HDL, LDL levels were researched at whole blood samples which are placed in another tube in biochemistry laboratory by using OLYMPUS AU 2700 autoanalyzer. For the measurement of PON levels in serum and BAL, Human Paraoxonase ELISA kit (Nova Tein Inc. Biosience. USA) was used.

3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mesut Subak, MD, mesutsubak@gmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Paraoxanaz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

It can be shared, after being published in scientific journals.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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