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Completed

NCT Number: NCT04175067

Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer

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

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Key information

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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

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 sphectrophotometry

Other names: Native thiol (μmol/L), Total thiol (μmol/L), Nativethiol/totalthiol(%), Disulfide/nativethiol(%), Disulfide/totalthiol(%)

Total Oxidant Capacity(μmolH2O2Equiv/L)

Diagnostic Test

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)

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 antioxidant capacity (TAC)

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

    TAC in mmol trolox equivalent/L

  2. total oxidant capacity (TOC)

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

    TOC in mmol H2O2 equivalent/L.

  3. Oxidative stress index (OSI)

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

    OSI in mmol trolox/L.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

Assessment of Thiol Disulfide Balance in Early Stage Endometrium Cancer

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2019
Registry last updated
Nov 22, 2019

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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