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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04258553
Other study ID # 19/09/2018-15-4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date February 4, 2020

Study information

Verified date April 2020
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date February 4, 2020
Est. primary completion date January 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Disulphide(µmol/L)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry
Total Oxidant Capacity(µmolH2O2Equiv/L)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry
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).

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Faculty of Medicine Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum native thiol level serum native thiol level in µmol/L preoperative in the morning or preprandial for healthy volunteers
Primary serum disulphide level serum disulphide level in µmol/L preoperative in the morning or preprandial for healthy volunteers
Primary serum total thiol level serum total thiol level in µmol/L preoperative in the morning or preprandial for healthy volunteers
Primary the disulphide/native thiol ratio the disulphide/native thiol ratio X (100 ) preoperative in the morning or preprandial for healthy volunteers
Primary disulphide/total thiol ratio disulphide/total thiol ratio X (100 ) preoperative in the morning or preprandial for healthy volunteers
Primary native thiol/total thiol ratio native thiol/total thiol ratio X (100 ) preoperative in the morning or preprandial for healthy volunteers
Secondary total oxidant capacity (TOC) TOC in mmol H2O2 equivalent/L preoperative in the morning or preprandial for healthy volunteers
Secondary total antioxidant capacity (TAC) TAC in mmol trolox equivalent/L preoperative in the morning or preprandial for healthy volunteers
Secondary Oxidative stress index (OSI) OSI in mmol trolox/L. preoperative in the morning or preprandial for healthy volunteers
Secondary ischaemia-modified albumin ischaemia-modified albumin in IU/mL preoperative in the morning or preprandial for healthy volunteers
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