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Paraoxanase Enzyme Activity in Patients With Pulmonary Diseases

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Take samples
Sponsored by
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases focused on measuring paraoxonase, lung diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Lung Malignancy

    Lung bening Diseases

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Difference of Paraoxonase Serum and BAL Levels between malignant and benign lung diseases
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 6, 2016
    Last Updated
    June 9, 2016
    Sponsor
    Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02800382
    Brief Title
    Paraoxanase Enzyme Activity in Patients With Pulmonary Diseases
    Official Title
    Bronchoalveolar Lavage Liq To Distinguish Benign and Malignant Pulmonary Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases
    Keywords
    paraoxonase, lung diseases

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lung Malignancy
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Lung bening Diseases
    Arm Type
    Other
    Arm Description
    Fiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.
    Intervention Type
    Other
    Intervention Name(s)
    Take samples
    Intervention Description
    Fiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.
    Primary Outcome Measure Information:
    Title
    Difference of Paraoxonase Serum and BAL Levels between malignant and benign lung diseases
    Description
    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.
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: There are not any medical contraindications for fiberoptic bronchoscopy (FOB) and bronchoalveolar lavage(BAL) Bronchoscopic symptom does not constitute an impediment status to performing. The following method has been obtained in accordance with FOB and BAL material. Exclusion Criteria: The presence of a medical contraindication to FOB and BAL During FOB not detecting or not technically making the suitable segment bronchus for BAL Not to be duly provided BAL materials. Inclusion criteria for the control(benign lung diseases) group; Have lung disease without malignancy The absence of addition disease The absence of medical contraindications for FOB and BAL 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mesut Subak, MD
    Organizational Affiliation
    mesutsubak@gmail.com
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    It can be shared, after being published in scientific journals.
    Citations:
    PubMed Identifier
    1673382
    Citation
    Gan KN, Smolen A, Eckerson HW, La Du BN. Purification of human serum paraoxonase/arylesterase. Evidence for one esterase catalyzing both activities. Drug Metab Dispos. 1991 Jan-Feb;19(1):100-6.
    Results Reference
    background
    PubMed Identifier
    20989488
    Citation
    MAZUR A. An enzyme in animal tissues capable of hydrolysing the phosphorus-fluorine bond of alkyl fluorophosphates. J Biol Chem. 1946 Jul;164:271-89. No abstract available.
    Results Reference
    background
    PubMed Identifier
    6318563
    Citation
    Geldmacher-von Mallinckrodt M, Diepgen TL, Duhme C, Hommel G. A study of the polymorphism and ethnic distribution differences of human serum paraoxonase. Am J Phys Anthropol. 1983 Nov;62(3):235-41. doi: 10.1002/ajpa.1330620302.
    Results Reference
    background
    PubMed Identifier
    8098250
    Citation
    Humbert R, Adler DA, Disteche CM, Hassett C, Omiecinski CJ, Furlong CE. The molecular basis of the human serum paraoxonase activity polymorphism. Nat Genet. 1993 Jan;3(1):73-6. doi: 10.1038/ng0193-73.
    Results Reference
    background
    PubMed Identifier
    9703197
    Citation
    Mackness B, Durrington PN, Mackness MI. Human serum paraoxonase. Gen Pharmacol. 1998 Sep;31(3):329-36. doi: 10.1016/s0306-3623(98)00028-7.
    Results Reference
    background
    PubMed Identifier
    18423402
    Citation
    Krzystek-Korpacka M, Boehm D, Matusiewicz M, Diakowska D, Grabowski K, Gamian A. Paraoxonase 1 (PON1) status in gastroesophageal malignancies and associated paraneoplastic syndromes - connection with inflammation. Clin Biochem. 2008 Jul;41(10-11):804-11. doi: 10.1016/j.clinbiochem.2008.03.012. Epub 2008 Apr 4.
    Results Reference
    background
    PubMed Identifier
    22860094
    Citation
    Griffin PE, Roddam LF, Belessis YC, Strachan R, Beggs S, Jaffe A, Cooley MA. Expression of PPARgamma and paraoxonase 2 correlated with Pseudomonas aeruginosa infection in cystic fibrosis. PLoS One. 2012;7(7):e42241. doi: 10.1371/journal.pone.0042241. Epub 2012 Jul 31.
    Results Reference
    background

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    Paraoxanase Enzyme Activity in Patients With Pulmonary Diseases

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