Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

NCT04177641 — Completed, 300 participants, Muğla Sıtkı Koçman University

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Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions

RegistryNCT04177641
StatusCompleted
Study typeObservational
Enrollment300 (Actual)
SponsorMuğla Sıtkı Koçman University (Other)
ConditionsOxidative Stress, Low Grade Squamous Intraepithelial Lesion, High-Grade Squamous Intraepithelial Lesions
InterventionsDisulphide(μmol/L), Total Oxidant Capacity(μmolH2O2Equiv/L) (Diagnostic test)
Datesstart 2018-09-20, primary completion 2020-01-01, completion 2020-01-10, first posted 2019-11-26, last updated 2020-02-06
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Oxidative Stress All trials for Low Grade Squamous Intraepithelial Lesion All trials of Disulphide(μmol/L) All trials of Total Oxidant Capacity(μmolH2O2Equiv/L)

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
low grade squamous intraepithelial lesion(LGSIL)Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)low grade squamous intraepithelial lesion(LGSIL) n=100
high grade squamous intraepithelial lesion(HGSIL)Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)high grade squamous intraepithelial lesion(HGSIL) n=100
Healthy controlsDiagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)Healthy volunteers n=100
  • Disulphide(μmol/L) (Diagnostic test), also known as Native thiol (μmol/L), Total thiol (μmol/L), Nativethiol/totalthiol(%), Disulfide/nativethiol(%), Disulfide/totalthiol(%): Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
  • Total Oxidant Capacity(μmolH2O2Equiv/L) (Diagnostic test), also known as Total Antioxidant Capacity(mmolTroloxEquiv/L), Oxidative stress Index (Arbitrary Unite): Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

+Outcome measures

Primary outcomes

  • serum native thiol level [baseline (preoperative in the morning or preprandial for healthy volunteers)]: serum native thiol level in μmol/L
  • serum disulphide level [baseline (preoperative in the morning or preprandial for healthy volunteers)]: serum disulphide level in μmol/L
  • serum total thiol level [baseline (preoperative in the morning or preprandial for healthy volunteers)]: serum total thiol level in μmol/L
  • the disulphide/native thiol ratio [baseline (preoperative in the morning or preprandial for healthy volunteers)]: the disulphide/native thiol ratio X (100 )
  • disulphide/total thiol ratio [baseline (preoperative in the morning or preprandial for healthy volunteers)]: disulphide/total thiol ratio X (100 )
  • native thiol/total thiol ratio [baseline (preoperative in the morning or preprandial for healthy volunteers)]: native thiol/total thiol ratio X (100 )

Secondary outcomes

  • total antioxidant capacity (TAC) [baseline (preoperative in the morning or preprandial for healthy volunteers)]: TAC in mmol trolox equivalent/L
  • 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.

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Mugla Sıtkı Kocman University Faculty of MedicineMuğlaTurkey (Türkiye)