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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04177641
Other study ID # 19/09/2018-15-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2018
Est. completion date January 10, 2020

Study information

Verified date February 2020
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 10, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • High-Grade Squamous Intraepithelial Lesions
  • Low Grade Squamous Intraepithelial Lesion
  • Oxidative Stress
  • Squamous Intraepithelial Lesions of the Cervix

Intervention

Diagnostic Test:
Disulphide(µmol/L)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Total Oxidant Capacity(µmolH2O2Equiv/L)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Faculty of Medicine Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum native thiol level serum native thiol level in µmol/L baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary serum disulphide level serum disulphide level in µmol/L baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary serum total thiol level serum total thiol level in µmol/L baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary the disulphide/native thiol ratio the disulphide/native thiol ratio X (100 ) baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary disulphide/total thiol ratio disulphide/total thiol ratio X (100 ) baseline (preoperative in the morning or preprandial for healthy volunteers)
Primary native thiol/total thiol ratio native thiol/total thiol ratio X (100 ) baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary total antioxidant capacity (TAC) TAC in mmol trolox equivalent/L baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary total oxidant capacity (TOC) TOC in mmol H2O2 equivalent/L baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary Oxidative stress index (OSI) OSI in mmol trolox/L. baseline (preoperative in the morning or preprandial for healthy volunteers)
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