Clinical trial NCT04175067: Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer
Official title: Assessment of Thiol Disulfide Balance in Early Stage Endometrium Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrium Cancer
Oxidative Stress
Keywords: Early stage
thiol disulfide hemostasis
malignancy
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum native thiol level
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: serum disulphide level
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: serum total thiol level
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: the disulphide/native thiol ratio
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: disulphide/total thiol ratio
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: native thiol/total thiol ratio
timeFrame: preoperative in the morning or preprandial for healthy volunteers
Secondary outcomes:
measure: total antioxidant capacity (TAC)
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: total oxidant capacity (TOC)
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: Oxidative stress index (OSI)
timeFrame: preoperative in the morning or preprandial for healthy volunteers
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Faculty of Medicine
Study officials:
affiliation: Mugla Sıtkı Kocman University Faculty of Medicine
name: Burak Sezgin
role: PRINCIPAL_INVESTIGATOR
References: