Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

Completed

• Conditions: Low Grade Squamous Intraepithelial Lesion; High-Grade Squamous Intraepithelial Lesions; Oxidative Stress
• Interventions: Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

• Registration Number: NCT04177641
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

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

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 Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low grade squamous intraepithelial lesion(LGSIL)	Disulphide(μmol/L)	low grade squamous intraepithelial lesion(LGSIL) n=100
Healthy controls	Total Oxidant Capacity(μmolH2O2Equiv/L)	Healthy volunteers n=100
high grade squamous intraepithelial lesion(HGSIL)	Total Oxidant Capacity(μmolH2O2Equiv/L)	high grade squamous intraepithelial lesion(HGSIL) n=100
Healthy controls	Disulphide(μmol/L)	Healthy volunteers n=100
low grade squamous intraepithelial lesion(LGSIL)	Total Oxidant Capacity(μmolH2O2Equiv/L)	low grade squamous intraepithelial lesion(LGSIL) n=100
high grade squamous intraepithelial lesion(HGSIL)	Disulphide(μmol/L)	high grade squamous intraepithelial lesion(HGSIL) n=100

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mugla Sıtkı Kocman University Faculty of Medicine; 🇹🇷 Mugla, Turkey