Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer

Completed

• Conditions: Oxidative Stress; Endometrium Cancer
• Interventions: Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

• Registration Number: NCT04175067
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

The purpose of this study is to investigate thiol-disulfide balance in early stage endometrium cancer patients.

Detailed Description

To date various oxidative stress paramaters were studied in patients with endometrial 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: 2018-08-01
• Primary Completion: 2019-10-31
• Status Verified: 2019-11
• Study Completion: 2019-11-15
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

• Histopathologically confirmed diagnosis of stage I endometrium cancer

Exclusion Criteria

• pulmonary disease
• pulmonary hypertension
• cardiac dysfunction
• renal dysfunction
• liver disease
• chronic ishemia
• 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
Endometrium cancer	Total Oxidant Capacity(μmolH2O2Equiv/L)	stage I endometrium cancer n=57
Healthy controls	Total Oxidant Capacity(μmolH2O2Equiv/L)	Healthy volunteers n=60
Healthy controls	Disulphide(μmol/L)	Healthy volunteers n=60
Endometrium cancer	Disulphide(μmol/L)	stage I endometrium cancer n=57

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
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 )
disulphide/total thiol ratio	preoperative in the morning or preprandial for healthy volunteers	disulphide/total thiol ratio X (100 )
native thiol/total thiol ratio	preoperative in the morning or preprandial for healthy volunteers	native thiol/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

Secondary Outcome Measures

Name	Time	Method
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.
total antioxidant capacity (TAC)	preoperative in the morning or preprandial for healthy volunteers	TAC in mmol trolox equivalent/L

Trial Locations

Locations (1)

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