Thiol Disulfide Balance in Cervix Cancer

Completed

• Conditions: Cervix Cancer; Oxidative Stress
• Interventions: Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L); Diagnostic Test: Ischemia Modified Albumin(IU/mL)

• Registration Number: NCT04258553
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

The aim of this research is to evaluate thiol-disulfide balance in cervix cancer patients

Detailed Description

To date various oxidative stress parameters were studied in patients with cervix cancer, 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: 2018-09-01
• Primary Completion: 2020-01-20
• Study Completion: 2020-02-04
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

• Histopathologically confirmed diagnosis of cervix cancer

Exclusion Criteria

• pulmonary disease
• pulmonary hypertension
• cardiac dysfunction
• renal dysfunction
• liver disease
• chronic ischemia
• systemic inflammation
• 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
Cervix cancer	Ischemia Modified Albumin(IU/mL)	Cervix cancer n=62
Cervix cancer	Disulphide(μmol/L)	Cervix cancer n=62
Healthy controls	Total Oxidant Capacity(μmolH2O2Equiv/L)	Healthy volunteers n=61
Cervix cancer	Total Oxidant Capacity(μmolH2O2Equiv/L)	Cervix cancer n=62
Healthy controls	Ischemia Modified Albumin(IU/mL)	Healthy volunteers n=61
Healthy controls	Disulphide(μmol/L)	Healthy volunteers n=61

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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