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Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Completed
CT.gov ID
NCT04177641
Collaborator
(none)
300
Enrollment
1
Location
15.7
Actual Duration (Months)
19.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Disulphide(μmol/L)
  • Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

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.

Study Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions
Actual Study Start Date :
Sep 20, 2018
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

Arm Intervention/Treatment
low grade squamous intraepithelial lesion(LGSIL)

low grade squamous intraepithelial lesion(LGSIL) n=100

Diagnostic Test: Disulphide(μmol/L)
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(%)

    • Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)
    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)

    		•
    high grade squamous intraepithelial lesion(HGSIL)

    high grade squamous intraepithelial lesion(HGSIL) n=100

    Diagnostic Test: Disulphide(μmol/L)
    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(%)

    • Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)
    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)

    		•
    Healthy controls

    Healthy volunteers n=100

    Diagnostic Test: Disulphide(μmol/L)
    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(%)

    • Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)
    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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. serum native thiol level [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      serum native thiol level in μmol/L

    2. serum disulphide level [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      serum disulphide level in μmol/L

    3. serum total thiol level [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      serum total thiol level in μmol/L

    4. the disulphide/native thiol ratio [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      the disulphide/native thiol ratio X (100 )

    5. disulphide/total thiol ratio [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      disulphide/total thiol ratio X (100 )

    6. native thiol/total thiol ratio [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      native thiol/total thiol ratio X (100 )

    Secondary Outcome Measures

    1. total antioxidant capacity (TAC) [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      TAC in mmol trolox equivalent/L

    2. total oxidant capacity (TOC) [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      TOC in mmol H2O2 equivalent/L

    3. Oxidative stress index (OSI) [baseline (preoperative in the morning or preprandial for healthy volunteers)]

      OSI in mmol trolox/L.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mugla Sıtkı Kocman University Faculty of Medicine Mugla Turkey 48000

    Sponsors and Collaborators

    • Muğla Sıtkı Koçman University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Burak Sezgin, Principal Investigator, Muğla Sıtkı Koçman University
    ClinicalTrials.gov Identifier:
    NCT04177641
    Other Study ID Numbers:
    • 19/09/2018-15-3
    First Posted:
    Nov 26, 2019
    Last Update Posted:
    Feb 6, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Burak Sezgin, Principal Investigator, Muğla Sıtkı Koçman University
    thiol disulfide balance
    preinvasive lesion
    cervix
    oxidative stress
    Additional relevant MeSH terms:
    Squamous Intraepithelial Lesions of the Cervix
    Antioxidants

    Study Results

    No Results Posted as of Feb 6, 2020