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Trial record 13 of 244105 for:    Diseases

Paraoxanase Enzyme Activity in Patients With Pulmonary Diseases

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ClinicalTrials.gov Identifier: NCT02800382
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Mesut Subak, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Lung Diseases Other: Take samples Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bronchoalveolar Lavage Liq To Distinguish Benign and Malignant Pulmonary Diseases
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
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.

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

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




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800382


Sponsors and Collaborators
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Investigators
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Study Chair: Mesut Subak, MD mesutsubak@gmail.com

Publications:
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Responsible Party: Mesut Subak, Chest Diseases Specialist Dr. Mesut Subak, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02800382     History of Changes
Other Study ID Numbers: Paraoxanaz
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It can be shared, after being published in scientific journals.

Keywords provided by Mesut Subak, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital:
paraoxonase
lung diseases

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases