Thiol Disulfide Balance in Cervix Cancer

NCT04258553 | Completed DMC

• 1 other identifier: 19/09/2018-15-4
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervix Cancer; Oxidative Stress

Keywords

thiol disulfide hemostasis; screening; early diagnosis

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 (4)

• total oxidant capacity (TOC)

  preoperative in the morning or preprandial for healthy volunteers

• total antioxidant capacity (TAC)

  preoperative in the morning or preprandial for healthy volunteers

• Oxidative stress index (OSI)

  preoperative in the morning or preprandial for healthy volunteers

• ischaemia-modified albumin

  preoperative in the morning or preprandial for healthy volunteers

Study Arms (2)

Cervix cancer

Cervix cancer n=62

Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L); Diagnostic Test: Ischemia Modified Albumin(IU/mL)

Healthy controls

Healthy volunteers n=61

Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L); Diagnostic Test: Ischemia Modified Albumin(IU/mL)

Interventions

Disulphide(μmol/L) DIAGNOSTIC_TEST

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

Also known as: Native thiol (μmol/L), Total thiol (μmol/L), Native thiol/totalthiol(%), Disulfide/native thiol(%), Disulfide/total thiol(%)

Cervix cancer; Healthy 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 spectrophotometry

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

Cervix cancer; Healthy controls

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).

Cervix cancer; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cervix cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The preoperative diagnosis of cervix cancer was made histopathologically by cervical biopsy. An experienced pathologist performed pathological analysis according to the surgical staging scheme of the International Federation of Gynaecology and Obstetrics.

You may qualify if:

• Histopathologically confirmed diagnosis of cervix cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum blood samples for each participant

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Disease

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Burak Sezgin, MD

  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: February 4, 2020
• First Posted: February 6, 2020
• Study Start: September 1, 2018
• Primary Completion: January 20, 2020
• Study Completion: February 4, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

TU (1)