NCT04175067

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

November 18, 2019

Last Update Submit

November 20, 2019

Conditions

Endometrium CancerOxidative Stress

Keywords

Early stagethiol disulfide hemostasismalignancy

Outcome Measures

Primary Outcomes (6)

  • serum native thiol level

    serum native thiol level in μmol/L

    preoperative in the morning or preprandial for healthy volunteers

  • serum disulphide level

    serum disulphide level in μmol/L

    preoperative in the morning or preprandial for healthy volunteers

  • serum total thiol level

    serum total thiol level in μmol/L

    preoperative in the morning or preprandial for healthy volunteers

  • the disulphide/native thiol ratio

    the disulphide/native thiol ratio X (100 )

    preoperative in the morning or preprandial for healthy volunteers

  • disulphide/total thiol ratio

    disulphide/total thiol ratio X (100 )

    preoperative in the morning or preprandial for healthy volunteers

  • native thiol/total thiol ratio

    native thiol/total thiol ratio X (100 )

    preoperative in the morning or preprandial for healthy volunteers

Secondary Outcomes (3)

  • total antioxidant capacity (TAC)

    preoperative in the morning or preprandial for healthy volunteers

  • total oxidant capacity (TOC)

    preoperative in the morning or preprandial for healthy volunteers

  • Oxidative stress index (OSI)

    preoperative in the morning or preprandial for healthy volunteers

Study Arms (2)

Endometrium cancer

stage I endometrium cancer n=57

Diagnostic Test: Disulphide(μmol/L)Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

Healthy controls

Healthy volunteers n=60

Diagnostic Test: Disulphide(μmol/L)Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)

Interventions

Disulphide(μmol/L)DIAGNOSTIC_TEST

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

Also known as: Native thiol (μmol/L), Total thiol (μmol/L), Nativethiol/totalthiol(%), Disulfide/nativethiol(%), Disulfide/totalthiol(%)
Endometrium cancerHealthy controls
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

Also known as: Total Antioxidant Capacity(mmolTroloxEquiv/L), Oxidative stress Index (Arbitrary Unite)
Endometrium cancerHealthy controls

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsendometrium cancer
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Histopathologically confirmed diagnosis of stage I endometrium cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum blood samples for aech participant

MeSH Terms

Conditions

Endometrial NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Burak Sezgin

    Mugla Sıtkı Kocman University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 22, 2019

Study Start

August 1, 2018

Primary Completion

October 31, 2019

Study Completion

November 15, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

TU(1)