Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer

Assessment of Thiol Disulfide Balance in Early Stage Endometrium Cancer

The purpose of this study is to investigate thiol-disulfide balance in early stage endometrium cancer patients.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Endometrium Cancer
• Intervention / Treatment: 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 endometrial 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): 117

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 Endometrium cancer was made histopathologically by endometrial biopsy. An experienced pathologist performed frozen section analysis according to the surgical staging scheme of the International Federation of Gynaecology and Obstetrics.

Description

Inclusion Criteria:

• Histopathologically confirmed diagnosis of stage I endometrium cancer

Exclusion Criteria:

• pulmonary disease
• pulmonary hypertension
• cardiac dysfunction
• renal dysfunction
• liver disease
• chronic ishemia
• 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
Endometrium cancer; stage I endometrium cancer n=57	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=60	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)

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 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
total oxidant capacity (TOC)	TOC in mmol H2O2 equivalent/L.	preoperative in the morning or preprandial for healthy volunteers

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): November 15, 2019

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (ACTUAL): November 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Early stage; malignancy; thiol disulfide hemostasis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: 09/08/2018-13-9

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