Oxidative StressNCT04177641
Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions
An observational study of Oxidative Stress and Low Grade Squamous Intraepithelial Lesion, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate Thiol-disulfide balance in patients with cervical preinvasive lesions Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Low Grade Squamous Intraepithelial Lesion, High-Grade Squamous Intraepithelial Lesions
- What is being tested?
- Disulphide(μmol/L) and Total Oxidant Capacity(μmolH2O2Equiv/L)
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2018to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The diagnosis of preinvasive cervical lesions was made histopathologically by cervical biopsy. An experienced pathologist performed histopathologic examinations
Who may be able to join
- Histopathologically confirmed diagnosis of LGSIL or HGSIL
Who cannot join
- pulmonary disease
- pulmonary hypertension
- cardiac dysfunction
- renal dysfunction
- liver disease
- chronic ishemia
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Faculty of Medicine
Muğla, 48000
About this study
Official title: Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions
The purpose of this study is to investigate Thiol-disulfide balance in patients with cervical preinvasive lesions
Read the 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.
- Conditions
- Oxidative Stress, Low Grade Squamous Intraepithelial Lesion, High-Grade Squamous Intraepithelial Lesions
- Being tested
- Disulphide(μmol/L), Total Oxidant Capacity(μmolH2O2Equiv/L)
- Keywords
- thiol disulfide balance, preinvasive lesion, cervix, oxidative stress
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disulphide(μmol/L)Diagnostic test
Also called Native thiol (μmol/L), Total thiol (μmol/L), Nativethiol/totalthiol(%), Disulfide/nativethiol(%)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
Total Oxidant Capacity(μmolH2O2Equiv/L)Diagnostic test
Also called Total Antioxidant Capacity(mmolTroloxEquiv/L), Oxidative stress Index (Arbitrary Unite)
Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
| Study group | Role | What they receive |
|---|---|---|
| low grade squamous intraepithelial lesion(LGSIL) | low grade squamous intraepithelial lesion(LGSIL) n=100 Receives: Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L) | |
| high grade squamous intraepithelial lesion(HGSIL) | high grade squamous intraepithelial lesion(HGSIL) n=100 Receives: Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L) | |
| Healthy controls | Healthy volunteers n=100 Receives: Diagnostic Test: Disulphide(μmol/L); Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum native thiol level
serum native thiol level in μmol/L
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum disulphide level
serum disulphide level in μmol/L
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum total thiol level
serum total thiol level in μmol/L
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
the disulphide/native thiol ratio
the disulphide/native thiol ratio X (100 )
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
disulphide/total thiol ratio
disulphide/total thiol ratio X (100 )
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
native thiol/total thiol ratio
native thiol/total thiol ratio X (100 )
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
Secondary outcomes (3)
total antioxidant capacity (TAC)
TAC in mmol trolox equivalent/L
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
total oxidant capacity (TOC)
TOC in mmol H2O2 equivalent/L
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
Oxidative stress index (OSI)
OSI in mmol trolox/L.
Measured: baseline (preoperative in the morning or preprandial for healthy volunteers)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start20 Sep 2018
- Primary completion1 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Sezgin, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177641
- Sponsor's protocol ID
- 19/09/2018-15-3
- Status last verified
- Feb 2020
- First submitted
- 24 Nov 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Thiol-disulfide Balance in Cervical Preinvasive Lesions
- ClinicalTrials.gov ID
- NCT04177641
- Acronym / sponsor ID
- 19/09/2018-15-3
- Conditions
- Oxidative Stress, Low Grade Squamous Intraepithelial Lesion, High-Grade Squamous Intraepithelial Lesions
- Keywords
- thiol disulfide balance, preinvasive lesion, cervix, oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate Thiol-disulfide balance in patients with cervical preinvasive lesions
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low grade squamous intraepithelial lesion(LGSIL) | – | Diagnostic Test: Disulphide(μmol/L), Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)low grade squamous intraepithelial lesion(LGSIL) n=100 |
| high grade squamous intraepithelial lesion(HGSIL) | – | Diagnostic Test: Disulphide(μmol/L), Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)high grade squamous intraepithelial lesion(HGSIL) n=100 |
| Healthy controls | – | Diagnostic Test: Disulphide(μmol/L), Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)Healthy volunteers n=100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The diagnosis of preinvasive cervical lesions was made histopathologically by cervical biopsy. An experienced pathologist performed histopathologic examinations
Key inclusion criteria (1 listed)
- Histopathologically confirmed diagnosis of LGSIL or HGSIL
Key exclusion criteria (12 listed)
- pulmonary disease
- pulmonary hypertension
- cardiac dysfunction
- renal dysfunction
- liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disulphide(μmol/L)Also: Native thiol (μmol/L), Total thiol (μmol/L), Nativethiol/totalthiol(%), Disulfide/nativethiol(%)Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry | Diagnostic test | Healthy controls, high grade squamous intraepithelial lesion(HGSIL), low grade squamous intraepithelial lesion(LGSIL) |
| Total Oxidant Capacity(μmolH2O2Equiv/L)Also: Total Antioxidant Capacity(mmolTroloxEquiv/L), Oxidative stress Index (Arbitrary Unite)Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry | Diagnostic test | Healthy controls, high grade squamous intraepithelial lesion(HGSIL), low grade squamous intraepithelial lesion(LGSIL) |
Primary outcome
serum native thiol level
Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum native thiol level in μmol/L
serum disulphide level
Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum disulphide level in μmol/L
serum total thiol level
Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
serum total thiol level in μmol/L
the disulphide/native thiol ratio
Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
the disulphide/native thiol ratio X (100 )
disulphide/total thiol ratio
Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
disulphide/total thiol ratio X (100 )
native thiol/total thiol ratio
Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
native thiol/total thiol ratio X (100 )
3 secondary outcomes
total antioxidant capacity (TAC)
Time frame: 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)
Oxidative stress index (OSI)
Time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress and Low Grade Squamous Intraepithelial Lesion, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum native thiol level (time frame: baseline (preoperative in the morning or preprandial for healthy volunteers)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.