Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

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

Detailed Description
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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.

Official Title
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Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions

Conditions
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Oxidative Stress, Low Grade Squamous Intraepithelial Lesion, High-Grade Squamous Intraepithelial Lesions

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| low grade squamous intraepithelial lesion(LGSIL)<br>low grade squamous intraepithelial lesion(LGSIL) n=100 | 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);|
| high grade squamous intraepithelial lesion(HGSIL)<br>high grade squamous intraepithelial lesion(HGSIL) n=100 | 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=100 | 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum native thiol level | serum native thiol level in μmol/L | baseline (preoperative in the morning or preprandial for healthy volunteers) | 
| serum disulphide level | serum disulphide level in μmol/L | baseline (preoperative in the morning or preprandial for healthy volunteers) | 
| serum total thiol level | serum total thiol level in μmol/L | baseline (preoperative in the morning or preprandial for healthy volunteers) | 
| the disulphide/native thiol ratio | the disulphide/native thiol ratio X (100 ) | baseline (preoperative in the morning or preprandial for healthy volunteers) | 
| disulphide/total thiol ratio | disulphide/total thiol ratio X (100 ) | baseline (preoperative in the morning or preprandial for healthy volunteers) | 
| native thiol/total thiol ratio | native thiol/total thiol ratio X (100 ) | baseline (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 | baseline (preoperative in the morning or preprandial for healthy volunteers) | 
| total oxidant capacity (TOC) | TOC in mmol H2O2 equivalent/L | baseline (preoperative in the morning or preprandial for healthy volunteers) | 
| Oxidative stress index (OSI) | OSI in mmol trolox/L. | baseline (preoperative in the morning or preprandial for healthy volunteers) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thiol disulfide balance, preinvasive lesion, cervix, oxidative stress