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Completed

NCT Number: NCT04177641

Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

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

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Key information

Conditions

Oxidative Stress High-Grade Squamous Intraepithelial Lesions Low Grade Squamous Intraepithelial Lesion Morphological and Microscopic Findings Pathological Conditions, Signs and Symptoms Squamous Intraepithelial Lesions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disulphide(μmol/L)

Diagnostic Test

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

Other names: Native thiol (μmol/L), Total thiol (μmol/L), Nativethiol/totalthiol(%), Disulfide/nativethiol(%), Disulfide/totalthiol(%)

Total Oxidant Capacity(μmolH2O2Equiv/L)

Diagnostic Test

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

Other names: Total Antioxidant Capacity(mmolTroloxEquiv/L), Oxidative stress Index (Arbitrary Unite)

Primary outcomes

  1. serum native thiol level

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    serum native thiol level in μmol/L

  2. serum disulphide level

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    serum disulphide level in μmol/L

  3. serum total thiol level

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    serum total thiol level in μmol/L

  4. the disulphide/native thiol ratio

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    the disulphide/native thiol ratio X (100 )

  5. disulphide/total thiol ratio

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    disulphide/total thiol ratio X (100 )

  6. native thiol/total thiol ratio

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    native thiol/total thiol ratio X (100 )

Secondary outcomes

  1. total antioxidant capacity (TAC)

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    TAC in mmol trolox equivalent/L

  2. total oxidant capacity (TOC)

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    TOC in mmol H2O2 equivalent/L

  3. Oxidative stress index (OSI)

    Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)

    OSI in mmol trolox/L.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2019
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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