- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177641
Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions
Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To date various oxidative stress paramaters were studied in patients with cervical preinvasive lesions, 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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Mugla, Turkey, 48000
- Mugla Sıtkı Kocman University Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Histopathologically confirmed diagnosis of LGSIL or HGSIL
Exclusion Criteria:
- pulmonary disease
- pulmonary hypertension
- cardiac dysfunction
- renal dysfunction
- liver disease
- chronic ishemia
- systemic inflammation
- other cervical biopy results than LGSIL or HGSIL
- 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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
low grade squamous intraepithelial lesion(LGSIL)
low grade squamous intraepithelial lesion(LGSIL) n=100
|
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Other Names:
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Other Names:
|
high grade squamous intraepithelial lesion(HGSIL)
high grade squamous intraepithelial lesion(HGSIL) n=100
|
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Other Names:
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Other Names:
|
Healthy controls
Healthy volunteers n=100
|
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Other Names:
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum native thiol level
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
serum native thiol level in μmol/L
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
serum disulphide level
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
serum disulphide level in μmol/L
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
serum total thiol level
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
serum total thiol level in μmol/L
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
the disulphide/native thiol ratio
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
the disulphide/native thiol ratio X (100 )
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
disulphide/total thiol ratio
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
disulphide/total thiol ratio X (100 )
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
native thiol/total thiol ratio
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
native thiol/total thiol ratio X (100 )
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total antioxidant capacity (TAC)
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
TAC in mmol trolox equivalent/L
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
total oxidant capacity (TOC)
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
TOC in mmol H2O2 equivalent/L
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
Oxidative stress index (OSI)
Time Frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
|
OSI in mmol trolox/L.
|
baseline (preoperative in the morning or preprandial for healthy volunteers)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19/09/2018-15-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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