Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer

• Sponsor: Muğla Sıtkı Koçman University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04175067
• Collaborator: (none)
• Enrollment: 117
• Location: 1
• Actual Duration (Months): 15.5
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometrium Cancer; Oxidative Stress	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 Design

• Study Type: Observational
• Actual Enrollment: 117 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Assessment of Thiol Disulfide Balance in Early Stage Endometrium Cancer
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Nov 15, 2019

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. serum native thiol level [preoperative in the morning or preprandial for healthy volunteers]

   serum native thiol level in μmol/L

2. serum disulphide level [preoperative in the morning or preprandial for healthy volunteers]

   serum disulphide level in μmol/L

3. serum total thiol level [preoperative in the morning or preprandial for healthy volunteers]

   serum total thiol level in μmol/L

4. the disulphide/native thiol ratio [preoperative in the morning or preprandial for healthy volunteers]

   the disulphide/native thiol ratio X (100 )

5. disulphide/total thiol ratio [preoperative in the morning or preprandial for healthy volunteers]

   disulphide/total thiol ratio X (100 )

6. native thiol/total thiol ratio [preoperative in the morning or preprandial for healthy volunteers]

   native thiol/total thiol ratio X (100 )

Secondary Outcome Measures

1. total antioxidant capacity (TAC) [preoperative in the morning or preprandial for healthy volunteers]

   TAC in mmol trolox equivalent/L

2. total oxidant capacity (TOC) [preoperative in the morning or preprandial for healthy volunteers]

   TOC in mmol H2O2 equivalent/L.

3. Oxidative stress index (OSI) [preoperative in the morning or preprandial for healthy volunteers]

   OSI in mmol trolox/L.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mugla Sıtkı Kocman University Faculty of Medicine	Mugla		Turkey	48000

Sponsors and Collaborators

• Muğla Sıtkı Koçman University

Investigators

• Principal Investigator: Burak Sezgin, Mugla Sıtkı Kocman University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Burak Sezgin, Principal Investigator, Muğla Sıtkı Koçman University
• ClinicalTrials.gov Identifier: NCT04175067
• Other Study ID Numbers: 09/08/2018-13-9
• First Posted: Nov 22, 2019
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Burak Sezgin, Principal Investigator, Muğla Sıtkı Koçman University: Early stage; thiol disulfide hemostasis; malignancy
• Additional relevant MeSH terms: Endometrial Neoplasms; Antioxidants

Study Results

No Results Posted as of Nov 22, 2019