Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- serum native thiol level
Study Overview
Brief Summary
The purpose of this study is to investigate Thiol-disulfide balance in patients with cervical preinvasive lesions
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
serum native thiol level
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum native thiol level in μmol/L
serum disulphide level
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum disulphide level in μmol/L
disulphide/total thiol ratio
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
disulphide/total thiol ratio X (100 )
native thiol/total thiol ratio
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
native thiol/total thiol ratio X (100 )
serum total thiol level
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum total thiol level in μmol/L
the disulphide/native thiol ratio
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
the disulphide/native thiol ratio X (100 )
Secondary Outcomes
- total antioxidant capacity (TAC)(baseline (preoperative in the morning or preprandial for healthy volunteers))
- total oxidant capacity (TOC)(baseline (preoperative in the morning or preprandial for healthy volunteers))
- Oxidative stress index (OSI)(baseline (preoperative in the morning or preprandial for healthy volunteers))
Investigators
Burak Sezgin
Principal Investigator
Muğla Sıtkı Koçman University