Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer

November 20, 2019 updated by: Burak Sezgin, Muğla Sıtkı Koçman University

Assessment of Thiol Disulfide Balance in Early Stage Endometrium Cancer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mugla, Turkey, 48000
        • Mugla Sıtkı Kocman University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Endometrium cancer
stage I endometrium cancer n=57
Diagnostic test: Disulphide(μmol/L)
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(%)
Diagnostic test: Total Oxidant Capacity(μmolH2O2Equiv/L)
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)
Healthy controls
Healthy volunteers n=60
Diagnostic test: Disulphide(μmol/L)
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(%)
Diagnostic test: Total Oxidant Capacity(μmolH2O2Equiv/L)
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serum native thiol level
Time Frame: preoperative in the morning or preprandial for healthy volunteers
serum native thiol level in μmol/L
preoperative in the morning or preprandial for healthy volunteers
serum disulphide level
Time Frame: preoperative in the morning or preprandial for healthy volunteers
serum disulphide level in μmol/L
preoperative in the morning or preprandial for healthy volunteers
serum total thiol level
Time Frame: preoperative in the morning or preprandial for healthy volunteers
serum total thiol level in μmol/L
preoperative in the morning or preprandial for healthy volunteers
the disulphide/native thiol ratio
Time Frame: preoperative in the morning or preprandial for healthy volunteers
the disulphide/native thiol ratio X (100 )
preoperative in the morning or preprandial for healthy volunteers
disulphide/total thiol ratio
Time Frame: preoperative in the morning or preprandial for healthy volunteers
disulphide/total thiol ratio X (100 )
preoperative in the morning or preprandial for healthy volunteers
native thiol/total thiol ratio
Time Frame: preoperative in the morning or preprandial for healthy volunteers
native thiol/total thiol ratio X (100 )
preoperative in the morning or preprandial for healthy volunteers

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
total antioxidant capacity (TAC)
Time Frame: preoperative in the morning or preprandial for healthy volunteers
TAC in mmol trolox equivalent/L
preoperative in the morning or preprandial for healthy volunteers
Oxidative stress index (OSI)
Time Frame: preoperative in the morning or preprandial for healthy volunteers
OSI in mmol trolox/L.
preoperative in the morning or preprandial for healthy volunteers
total oxidant capacity (TOC)
Time Frame: preoperative in the morning or preprandial for healthy volunteers
TOC in mmol H2O2 equivalent/L.
preoperative in the morning or preprandial for healthy volunteers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Burak Sezgin, Mugla Sıtkı Kocman University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09/08/2018-13-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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