Clinical trial NCT04258553: Thiol Disulfide Balance in Cervix Cancer
Official title: Evaluation of Thiol Disulfide Balance in Cervix Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix Cancer
Oxidative Stress
Keywords: thiol disulfide hemostasis
screening
early diagnosis
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 123
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 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.

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

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.

Eligibility criteria: 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

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 oxidant capacity (TOC)
timeFrame: preoperative in the morning or preprandial for healthy volunteers
measure: total antioxidant capacity (TAC)
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
measure: ischaemia-modified albumin
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, MD
role: PRINCIPAL_INVESTIGATOR
References: