Thiol Disulfide Balance in Cervix Cancer

Evaluation of Thiol Disulfide Balance in Cervix Cancer

The aim of this research is to evaluate thiol-disulfide balance in cervix cancer patients

Study Overview

• Status: Completed
• Conditions: Cervix Cancer; Oxidative Stress
• Intervention / Treatment: Diagnostic test: Disulphide(μmol/L); Diagnostic test: Total Oxidant Capacity(μmolH2O2Equiv/L); Diagnostic test: Ischemia Modified Albumin(IU/mL)

Detailed Description

To date various oxidative stress parameters were studied in patients with cervix cancer, 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 Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Turkey
  • Mugla, Turkey, 48000
    • Mugla Sıtkı Kocman University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The preoperative diagnosis of cervix cancer was made histopathologically by cervical biopsy. An experienced pathologist performed pathological analysis according to the surgical staging scheme of the International Federation of Gynaecology and Obstetrics.

Description

Inclusion Criteria:

• Histopathologically confirmed diagnosis of cervix cancer

Exclusion Criteria:

• pulmonary disease
• pulmonary hypertension
• cardiac dysfunction
• renal dysfunction
• liver disease
• chronic ischemia
• systemic inflammation
• 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cervix cancer; Cervix cancer n=62	Diagnostic test: Disulphide(μmol/L); Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry; Other Names: Native thiol (μmol/L); Total thiol (μmol/L); Native thiol/totalthiol(%); Disulfide/native thiol(%); Disulfide/total thiol(%); Diagnostic test: Total Oxidant Capacity(μmolH2O2Equiv/L); Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry; Other Names: Total Antioxidant Capacity(mmolTroloxEquiv/L); Oxidative stress Index (Arbitrary Unite); Diagnostic test: Ischemia Modified Albumin(IU/mL); The serum Ischemia Modified Albumin concentrations were measured as described by Bar-Or et al. (Bar-Or et al. 2000).
Healthy controls; Healthy volunteers n=61	Diagnostic test: Disulphide(μmol/L); Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry; Other Names: Native thiol (μmol/L); Total thiol (μmol/L); Native thiol/totalthiol(%); Disulfide/native thiol(%); Disulfide/total thiol(%); Diagnostic test: Total Oxidant Capacity(μmolH2O2Equiv/L); Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry; Other Names: Total Antioxidant Capacity(mmolTroloxEquiv/L); Oxidative stress Index (Arbitrary Unite); Diagnostic test: Ischemia Modified Albumin(IU/mL); The serum Ischemia Modified Albumin concentrations were measured as described by Bar-Or et al. (Bar-Or et al. 2000).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum native thiol level	serum native thiol level in μmol/L	preoperative in the morning or preprandial for healthy volunteers
serum disulphide level	serum disulphide level in μmol/L	preoperative in the morning or preprandial for healthy volunteers
serum total thiol level	serum total thiol level in μmol/L	preoperative in the morning or preprandial for healthy volunteers
the disulphide/native thiol ratio	the disulphide/native thiol ratio X (100 )	preoperative in the morning or preprandial for healthy volunteers
disulphide/total thiol ratio	disulphide/total thiol ratio X (100 )	preoperative in the morning or preprandial for healthy volunteers
native thiol/total thiol ratio	native thiol/total thiol ratio X (100 )	preoperative in the morning or preprandial for healthy volunteers

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total oxidant capacity (TOC)	TOC in mmol H2O2 equivalent/L	preoperative in the morning or preprandial for healthy volunteers
total antioxidant capacity (TAC)	TAC in mmol trolox equivalent/L	preoperative in the morning or preprandial for healthy volunteers
Oxidative stress index (OSI)	OSI in mmol trolox/L.	preoperative in the morning or preprandial for healthy volunteers
ischaemia-modified albumin	ischaemia-modified albumin in IU/mL	preoperative in the morning or preprandial for healthy volunteers

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Principal Investigator: Burak Sezgin, MD, Mugla Sıtkı Kocman University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): January 20, 2020
• Study Completion (ACTUAL): February 4, 2020

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: screening; early diagnosis; thiol disulfide hemostasis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: 19/09/2018-15-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No