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Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

M

Muğla Sıtkı Koçman University

Status

Completed

Conditions

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

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04177641
19/09/2018-15-3

Details and patient eligibility

About

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

Full 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.

Enrollment

300 patients

Sex

Female

Ages

18+ years old

Volunteers

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

Trial design

300 participants in 3 patient groups

low grade squamous intraepithelial lesion(LGSIL)
Description:
low grade squamous intraepithelial lesion(LGSIL) n=100
Treatment:
Diagnostic Test: Disulphide(μmol/L)
Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)
high grade squamous intraepithelial lesion(HGSIL)
Description:
high grade squamous intraepithelial lesion(HGSIL) n=100
Treatment:
Diagnostic Test: Disulphide(μmol/L)
Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)
Healthy controls
Description:
Healthy volunteers n=100
Treatment:
Diagnostic Test: Disulphide(μmol/L)
Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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