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NCT Number: NCT04258553

Thiol Disulfide Balance in Cervix Cancer

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

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Key information

Conditions

Cervix Cancer Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disulphide(μmol/L)

Diagnostic Test

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry

Other names: Native thiol (μmol/L), Total thiol (μmol/L), Native thiol/totalthiol(%), Disulfide/native thiol(%), Disulfide/total thiol(%)

Total Oxidant Capacity(μmolH2O2Equiv/L)

Diagnostic Test

Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry

Other names: Total Antioxidant Capacity(mmolTroloxEquiv/L), Oxidative stress Index (Arbitrary Unite)

Ischemia Modified Albumin(IU/mL)

Diagnostic Test

The serum Ischemia Modified Albumin concentrations were measured as described by Bar-Or et al. (Bar-Or et al. 2000).

Primary outcomes

  1. serum native thiol level

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    serum native thiol level in μmol/L

  2. serum disulphide level

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    serum disulphide level in μmol/L

  3. serum total thiol level

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    serum total thiol level in μmol/L

  4. the disulphide/native thiol ratio

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    the disulphide/native thiol ratio X (100 )

  5. disulphide/total thiol ratio

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    disulphide/total thiol ratio X (100 )

  6. native thiol/total thiol ratio

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    native thiol/total thiol ratio X (100 )

Secondary outcomes

  1. total oxidant capacity (TOC)

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    TOC in mmol H2O2 equivalent/L

  2. total antioxidant capacity (TAC)

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    TAC in mmol trolox equivalent/L

  3. Oxidative stress index (OSI)

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    OSI in mmol trolox/L.

  4. ischaemia-modified albumin

    Time frame: preoperative in the morning or preprandial for healthy volunteers

    ischaemia-modified albumin in IU/mL

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

Evaluation of Thiol Disulfide Balance in Cervix Cancer

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2020
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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