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CompletedNCT04177641Updated Feb 6, 2020

Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

An observational study in Oxidative Stress, Low Grade Squamous Intraepithelial Lesion and High-Grade Squamous Intraepithelial Lesions, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Muğla Sıtkı Koçman University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

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

Keywords

  • thiol disulfide balance
  • preinvasive lesion
  • cervix
  • oxidative stress
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In context

Squamous Intraepithelial Lesions of the Cervix

49 studies on the registry are indexed under Squamous Intraepithelial Lesions of the Cervix; 13 are open to participants now.

This study's enrollment of 300 is close to the median of 300 across 15 observational studies indexed under Squamous Intraepithelial Lesions of the Cervix.

Browse Squamous Intraepithelial Lesions of the Cervix studies →

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The diagnosis of preinvasive cervical lesions was made histopathologically by cervical biopsy. An experienced pathologist performed histopathologic examinations

Inclusion criteria

  • Histopathologically confirmed diagnosis of LGSIL or HGSIL

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • low grade squamous intraepithelial lesion(LGSIL)

    low grade squamous intraepithelial lesion(LGSIL) n=100

    Diagnostic Test: Disulphide(μmol/L) · Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

  • high grade squamous intraepithelial lesion(HGSIL)

    high grade squamous intraepithelial lesion(HGSIL) n=100

    Diagnostic Test: Disulphide(μmol/L) · Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

  • Healthy controls

    Healthy volunteers n=100

    Diagnostic Test: Disulphide(μmol/L) · Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

Interventions

  • Diagnostic testDisulphide(μmol/L)

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

    Also known as: Native thiol (μmol/L), Total thiol (μmol/L), Nativethiol/totalthiol(%), Disulfide/nativethiol(%), Disulfide/totalthiol(%)

  • Diagnostic testTotal Oxidant Capacity(μmolH2O2Equiv/L)

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

    Also known as: Total Antioxidant Capacity(mmolTroloxEquiv/L), Oxidative stress Index (Arbitrary Unite)

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What researchers measure

Primary outcomes

  1. serum native thiol level

    serum native thiol level in μmol/L

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

  2. serum disulphide level

    serum disulphide level in μmol/L

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

  3. serum total thiol level

    serum total thiol level in μmol/L

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

  4. the disulphide/native thiol ratio

    the disulphide/native thiol ratio X (100 )

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

  5. disulphide/total thiol ratio

    disulphide/total thiol ratio X (100 )

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

  6. native thiol/total thiol ratio

    native thiol/total thiol ratio X (100 )

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

Secondary outcomes

  1. total antioxidant capacity (TAC)

    TAC in mmol trolox equivalent/L

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

  2. total oxidant capacity (TOC)

    TOC in mmol H2O2 equivalent/L

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

  3. Oxidative stress index (OSI)

    OSI in mmol trolox/L.

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

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Study locations

1 site
  • Mugla Sıtkı Kocman University Faculty of Medicine
    Mugla, 48000, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04177641
Lead sponsor
Muğla Sıtkı Koçman University
Responsible party
Burak Sezgin (Principal Investigator, Muğla Sıtkı Koçman University) — Principal investigator
First posted
Nov 26, 2019
Start date
Sep 20, 2018
Primary completion
Jan 1, 2020
Completion
Jan 10, 2020
Last update
Feb 6, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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