Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

NCT ID: NCT04177641

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-20

Study Completion Date

2020-01-10

Brief Summary

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The purpose of this study is to investigate Thiol-disulfide balance in patients with cervical preinvasive lesions

Detailed Description

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To date various oxidative stress paramaters were studied in patients with cervical preinvasive lesions, however dynamic thiol disulfide hemostasis has not been previously investigated. The thiol-disulfide balance in the circulation will be measured by the automated system created by Erel \& Neselioglu(1).

References 1- Erel O, Neselioglu S. A novel and automated assay for thiol/ disulphide homeostasis. Clin Biochem 2014;47:326-32. doi:10.1016/ j.clinbiochem.2014.09.026.

Conditions

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Oxidative Stress Low Grade Squamous Intraepithelial Lesion High-Grade Squamous Intraepithelial Lesions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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low grade squamous intraepithelial lesion(LGSIL)

low grade squamous intraepithelial lesion(LGSIL) n=100

Disulphide(μmol/L)

Intervention Type DIAGNOSTIC_TEST

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Total Oxidant Capacity(μmolH2O2Equiv/L)

Intervention Type DIAGNOSTIC_TEST

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

high grade squamous intraepithelial lesion(HGSIL)

high grade squamous intraepithelial lesion(HGSIL) n=100

Disulphide(μmol/L)

Intervention Type DIAGNOSTIC_TEST

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Total Oxidant Capacity(μmolH2O2Equiv/L)

Intervention Type DIAGNOSTIC_TEST

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Healthy controls

Healthy volunteers n=100

Disulphide(μmol/L)

Intervention Type DIAGNOSTIC_TEST

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Total Oxidant Capacity(μmolH2O2Equiv/L)

Intervention Type DIAGNOSTIC_TEST

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Interventions

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Disulphide(μmol/L)

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Intervention Type DIAGNOSTIC_TEST

Total Oxidant Capacity(μmolH2O2Equiv/L)

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Native thiol (μmol/L) Total thiol (μmol/L) Nativethiol/totalthiol(%) Disulfide/nativethiol(%) Disulfide/totalthiol(%) Total Antioxidant Capacity(mmolTroloxEquiv/L) Oxidative stress Index (Arbitrary Unite)

Eligibility Criteria

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Inclusion Criteria

• Histopathologically confirmed diagnosis of LGSIL or HGSIL

Exclusion Criteria

* pulmonary disease
* pulmonary hypertension
* cardiac dysfunction
* renal dysfunction
* liver disease
* chronic ishemia
* systemic inflammation
* other cervical biopy results than LGSIL or HGSIL
* concomitant malignancy
* patients who use vitamin A,C or E (antioxidant vitamins)
* patients who use smoke • patients who use drink alcohol
* patients who use addictive for any drug
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Burak Sezgin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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19/09/2018-15-3

Identifier Type: -

Identifier Source: org_study_id

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