Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

Oxidative Stress Clinical Trial

Official title:

Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177641
• Other study ID #: 19/09/2018-15-3
• Status: Completed
• Start date: September 20, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: February 2020
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 10, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High-Grade Squamous Intraepithelial Lesions
• Low Grade Squamous Intraepithelial Lesion
• Oxidative Stress
• Squamous Intraepithelial Lesions of the Cervix

Intervention

Diagnostic Test:
• Disulphide(µmol/L)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
• Total Oxidant Capacity(µmolH2O2Equiv/L)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Faculty of Medicine	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum native thiol level	serum native thiol level in µmol/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary	serum disulphide level	serum disulphide level in µmol/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary	serum total thiol level	serum total thiol level in µmol/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary	the disulphide/native thiol ratio	the disulphide/native thiol ratio X (100 )	baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary	disulphide/total thiol ratio	disulphide/total thiol ratio X (100 )	baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary	native thiol/total thiol ratio	native thiol/total thiol ratio X (100 )	baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary	total antioxidant capacity (TAC)	TAC in mmol trolox equivalent/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary	total oxidant capacity (TOC)	TOC in mmol H2O2 equivalent/L	baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary	Oxidative stress index (OSI)	OSI in mmol trolox/L.	baseline (preoperative in the morning or preprandial for healthy volunteers)