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Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04177641
Enrollment
300
Registered
2019-11-26
Start date
2018-09-20
Completion date
2020-01-10
Last updated
2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

thiol disulfide balance, preinvasive lesion, cervix, oxidative stress

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.

Interventions

DIAGNOSTIC_TESTDisulphide(μmol/L)

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Sponsors

Muğla Sıtkı Koçman University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
native thiol/total thiol ratiobaseline (preoperative in the morning or preprandial for healthy volunteers)native thiol/total thiol ratio X (100 )
serum total thiol levelbaseline (preoperative in the morning or preprandial for healthy volunteers)serum total thiol level in μmol/L
the disulphide/native thiol ratiobaseline (preoperative in the morning or preprandial for healthy volunteers)the disulphide/native thiol ratio X (100 )
disulphide/total thiol ratiobaseline (preoperative in the morning or preprandial for healthy volunteers)disulphide/total thiol ratio X (100 )
serum native thiol levelbaseline (preoperative in the morning or preprandial for healthy volunteers)serum native thiol level in μmol/L
serum disulphide levelbaseline (preoperative in the morning or preprandial for healthy volunteers)serum disulphide level in μmol/L

Secondary

MeasureTime frameDescription
total oxidant capacity (TOC)baseline (preoperative in the morning or preprandial for healthy volunteers)TOC in mmol H2O2 equivalent/L
Oxidative stress index (OSI)baseline (preoperative in the morning or preprandial for healthy volunteers)OSI in mmol trolox/L.
total antioxidant capacity (TAC)baseline (preoperative in the morning or preprandial for healthy volunteers)TAC in mmol trolox equivalent/L

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026