Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions

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

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Low Grade Squamous Intraepithelial Lesion; High-Grade Squamous Intraepithelial Lesions
• Intervention / Treatment: Diagnostic test: Disulphide(μmol/L); Diagnostic test: Total Oxidant Capacity(μmolH2O2Equiv/L)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Turkey
  • Mugla, Turkey, 48000
    • Mugla Sıtkı Kocman University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The diagnosis of preinvasive cervical lesions was made histopathologically by cervical biopsy. An experienced pathologist performed histopathologic examinations

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low grade squamous intraepithelial lesion(LGSIL); low grade squamous intraepithelial lesion(LGSIL) n=100	Diagnostic test: Disulphide(μmol/L); Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry; Other Names: Native thiol (μmol/L); Total thiol (μmol/L); Nativethiol/totalthiol(%); Disulfide/nativethiol(%); Disulfide/totalthiol(%); 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; Other Names: Total Antioxidant Capacity(mmolTroloxEquiv/L); Oxidative stress Index (Arbitrary Unite)
high grade squamous intraepithelial lesion(HGSIL); high grade squamous intraepithelial lesion(HGSIL) n=100	Diagnostic test: Disulphide(μmol/L); Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry; Other Names: Native thiol (μmol/L); Total thiol (μmol/L); Nativethiol/totalthiol(%); Disulfide/nativethiol(%); Disulfide/totalthiol(%); 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; Other Names: Total Antioxidant Capacity(mmolTroloxEquiv/L); Oxidative stress Index (Arbitrary Unite)
Healthy controls; Healthy volunteers n=100	Diagnostic test: Disulphide(μmol/L); Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry; Other Names: Native thiol (μmol/L); Total thiol (μmol/L); Nativethiol/totalthiol(%); Disulfide/nativethiol(%); Disulfide/totalthiol(%); 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; Other Names: Total Antioxidant Capacity(mmolTroloxEquiv/L); Oxidative stress Index (Arbitrary Unite)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum native thiol level	serum native thiol level in μmol/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
serum disulphide level	serum disulphide level in μmol/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
serum total thiol level	serum total thiol level in μmol/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
the disulphide/native thiol ratio	the disulphide/native thiol ratio X (100 )	baseline (preoperative in the morning or preprandial for healthy volunteers)
disulphide/total thiol ratio	disulphide/total thiol ratio X (100 )	baseline (preoperative in the morning or preprandial for healthy volunteers)
native thiol/total thiol ratio	native thiol/total thiol ratio X (100 )	baseline (preoperative in the morning or preprandial for healthy volunteers)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total antioxidant capacity (TAC)	TAC in mmol trolox equivalent/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
total oxidant capacity (TOC)	TOC in mmol H2O2 equivalent/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
Oxidative stress index (OSI)	OSI in mmol trolox/L.	baseline (preoperative in the morning or preprandial for healthy volunteers)

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: oxidative stress; cervix; thiol disulfide balance; preinvasive lesion
• Additional Relevant MeSH Terms: Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions of the Cervix; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: 19/09/2018-15-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No