Clinical trial NCT04177641: Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions
Official title: Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Low Grade Squamous Intraepithelial Lesion
High-Grade Squamous Intraepithelial Lesions
Keywords: thiol disulfide balance
preinvasive lesion
cervix
oxidative stress
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The diagnosis of preinvasive cervical lesions was made histopathologically by cervical biopsy. An experienced pathologist performed histopathologic examinations

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum native thiol level
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
measure: serum disulphide level
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
measure: serum total thiol level
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
measure: the disulphide/native thiol ratio
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
measure: disulphide/total thiol ratio
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
measure: native thiol/total thiol ratio
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary outcomes:
measure: total antioxidant capacity (TAC)
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
measure: total oxidant capacity (TOC)
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
measure: Oxidative stress index (OSI)
timeFrame: baseline (preoperative in the morning or preprandial for healthy volunteers)
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Faculty of Medicine
Study officials:
References: