Lung DiseasesNCT02800382

Paraoxanase Enzyme Activity in Patients With Pulmonary Diseases

A study testing Take samples in people with Lung Diseases, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Diseases
What is being tested?: Take samples
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: No sites listed yet
Study dates: Jan 2012to Jun 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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.

About this study

Official title: 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).

Read the detailed description

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.

Conditions: Lung Diseases
Being tested: Take samples
Keywords: paraoxonase, lung diseases
Medical subject headings: Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02800382
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Take samples

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2016

First posted15 Jun 2016 (estimated)
Study startJan 2012
Primary completionDec 2013
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Lung DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02800382
Sponsor's protocol ID: Paraoxanaz
Status last verified: Jun 2016
First submitted: 6 Jun 2016
Last updated: 15 Jun 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No: It can be shared, after being published in scientific journals.

Publications

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.
PubMed 1673382
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.
PubMed 20989488
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.
PubMed 6318563
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.
PubMed 8098250
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.
PubMed 9703197
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.
PubMed 18423402
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.
PubMed 22860094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bronchoalveolar Lavage Liq To Distinguish Benign and Malignant Pulmonary Diseases
ClinicalTrials.gov ID: NCT02800382
Acronym / sponsor ID: Paraoxanaz
Conditions: Lung Diseases
Keywords: paraoxonase, lung diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
Study start: Jan 2012
Primary completion: Dec 2013 (actual)
Study completion: Jun 2016 (actual)
First posted: 15 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lung Malignancy	Other	Other: Take samplesFiberoptic 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.
Lung bening Diseases	Other	Other: Take samplesFiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Take samplesFiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.	Other	Lung Malignancy, Lung bening Diseases

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
Background: PubMed 1673382Gan 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.
Background: PubMed 20989488MAZUR 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.
Background: PubMed 6318563Geldmacher-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.
Background: PubMed 8098250Humbert 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.
Background: PubMed 9703197Mackness B, Durrington PN, Mackness MI. Human serum paraoxonase. Gen Pharmacol. 1998 Sep;31(3):329-36. doi: 10.1016/s0306-3623(98)00028-7.
Background: PubMed 18423402Krzystek-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.
Background: PubMed 22860094Griffin 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.
Individual participant dataSharing planned: No. It can be shared, after being published in scientific journals.

Related trials for Lung Diseases

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mesut Subak, MD study chair

mesutsubak@gmail.com

Questions about this trial

What is this clinical trial studying?

A study testing Take samples in people with Lung Diseases, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference of Paraoxonase Serum and BAL Levels between malignant and benign lung diseases (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02800382, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.