Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer

Study Overview
=================
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.

Official Title
-----------------
Assessment of Thiol Disulfide Balance in Early Stage Endometrium Cancer

Conditions
-----------------
Endometrium Cancer, Oxidative Stress

Intervention / Treatment
-----------------
* Diagnostic Test: Disulphide(μmol/L)
* Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometrium cancer<br>stage I endometrium cancer n=57 | Diagnostic Test: Disulphide(μmol/L)<br>* Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry<br>* Other names: Disulfide/totalthiol(%);Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)<br>* Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry<br>* Other names: Oxidative stress Index (Arbitrary Unite);|
| Healthy controls<br>Healthy volunteers n=60 | Diagnostic Test: Disulphide(μmol/L)<br>* Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry<br>* Other names: Disulfide/totalthiol(%);Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)<br>* Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry<br>* Other names: 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 | preoperative in the morning or preprandial for healthy volunteers | 
| serum disulphide level | serum disulphide level in μmol/L | preoperative in the morning or preprandial for healthy volunteers | 
| serum total thiol level | serum total thiol level in μmol/L | preoperative in the morning or preprandial for healthy volunteers | 
| the disulphide/native thiol ratio | the disulphide/native thiol ratio X (100 ) | preoperative in the morning or preprandial for healthy volunteers | 
| disulphide/total thiol ratio | disulphide/total thiol ratio X (100 ) | preoperative in the morning or preprandial for healthy volunteers | 
| native thiol/total thiol ratio | native thiol/total thiol ratio X (100 ) | 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 | preoperative in the morning or preprandial for healthy volunteers | 
| total oxidant capacity (TOC) | TOC in mmol H2O2 equivalent/L. | preoperative in the morning or preprandial for healthy volunteers | 
| Oxidative stress index (OSI) | OSI in mmol trolox/L. | preoperative in the morning or preprandial for healthy volunteers | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early stage, thiol disulfide hemostasis, malignancy