NCT02800382

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

June 6, 2016

Last Update Submit

June 9, 2016

Conditions

Keywords

paraoxonaselung diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 month

Study Arms (2)

Lung Malignancy

OTHER

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

Lung bening Diseases

OTHER

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

Interventions

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

Lung MalignancyLung bening Diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Have lung disease without malignancy
  • The absence of addition disease
  • The absence of medical contraindications for FOB and BAL
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 1673382BACKGROUND
  • 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.

    PMID: 20989488BACKGROUND
  • 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.

    PMID: 6318563BACKGROUND
  • 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.

    PMID: 8098250BACKGROUND
  • 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.

    PMID: 9703197BACKGROUND
  • 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.

    PMID: 18423402BACKGROUND
  • 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.

    PMID: 22860094BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Mesut Subak, MD

    mesutsubak@gmail.com

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chest Diseases Specialist Dr. Mesut Subak

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 15, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2016

Last Updated

June 15, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

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