Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

NCT04177641 | Completed

• 1 other identifier: 19/09/2018-15-3
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

thiol disulfide balance; preinvasive lesion; cervix; oxidative stress

Outcome Measures

Primary Outcomes (6)

• serum native thiol level

  serum native thiol level in μmol/L

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

• serum disulphide level

  serum disulphide level in μmol/L

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

• serum total thiol level

  serum total thiol level in μmol/L

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

• the disulphide/native thiol ratio

  the disulphide/native thiol ratio X (100 )

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

• disulphide/total thiol ratio

  disulphide/total thiol ratio X (100 )

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

• native thiol/total thiol ratio

  native thiol/total thiol ratio X (100 )

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

Secondary Outcomes (3)

• total antioxidant capacity (TAC)

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

• total oxidant capacity (TOC)

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

• Oxidative stress index (OSI)

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

Study Arms (3)

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

Disulphide(μmol/L) DIAGNOSTIC_TEST

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(%)

Healthy controls; high grade squamous intraepithelial lesion(HGSIL); low grade squamous intraepithelial lesion(LGSIL)

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

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

Healthy controls; high grade squamous intraepithelial lesion(HGSIL); low grade squamous intraepithelial lesion(LGSIL)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: histopathologically confirmed LGSIL or HGSIL
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Histopathologically confirmed diagnosis of LGSIL or HGSIL

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 26, 2019
• Study Start: September 20, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 10, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

TU (1)