Polycystic Ovary SyndromeNCT03765905
Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,
An observational study of Polycystic Ovary Syndrome, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- study
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2017to 1 Feb 2018
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 40 women diagnosed with PCOS between the ages of 18-35
Who may be able to join
- Clinical diagnosis of PCOS
- 18-35 years old
Who cannot join
- Endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease and congenital adrenal hyperplasia), systemic disease (eg asthma), collagen disorder, hypercholesterolemia, sickle cell anemia or neoplasm,
- Coronary artery disease , angina or myocardial infarction, or any known vascular, infectious, or inflammatory disease, including hypertension, coronary arterioscitis, and electrocardiographic changes;
- Use of any medication (e.g., insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, corticosteroids and gonadotropin releasing hormone agonists and antagonists) within the previous 3 months;
- Abnormal serum albumin concentration (normal concentration, 30-55 g / l),
- Abnormal troponin I concentration,
- Present smoker,
- Abnormal renal, hepatic and thyroid function test results;
- Refusing to participate in the work.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Medicine
Trabzon, Ortahisar, 61000
About this study
The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index
Read the detailed description
The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index.
This will be a prospective clinical laboratory study,It will include women with PCOS diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be included in the study group, which will be included in the survey after being approved for participation in the survey from field trials. Forty patients who will not have any complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control group but who had no PCOS o rany other systemic problems and will be similar in terms of age group and body mass index will be included in the study after being approved for participation in the study. From the study and control group, 5 mL of blood will be taken from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1, SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- study
- Keywords
- PCOS, SCUBE, Cardiovascular disease
- Medical subject headings
- Polycystic Ovary Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
studyDiagnostic test
Scube-1 scube-2 scube-3
| Study group | Role | What they receive |
|---|---|---|
| PCOS diagnosis area | The study group consisted of 40 reproductive age women between 18th and 35th years old women who were PCOS diagnosis (according to the 2003 Rotherdam criteria) Receives: Diagnostic Test: study | |
| PCOS is not diagnosed | Forty patients who did not have any complaints between the ages of 18-35 who applied to the gynecology policlinic as a control group but who had no PCOS orany other systemic problems and were similar in terms of age group and body mass index were included in the study after being approved for participation in the study Receives: Diagnostic Test: study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum SCUBE 1
Serum scube1 in microgram
Measured: 01.01.2017-31.12.2017
Serum SCUBE 2
Serum scube2 in microgram
Measured: 01.01.2017-31.12.2017
Serum SCUBE 3
Serum scube3 in microgram
Measured: 01.01.2017-31.12.2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Dec 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
- Investigators
- Süleyman Güven, Prof, Principal investigator, Karadeniz TU Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765905
- Sponsor's protocol ID
- Karadeniz Technical University
- Status last verified
- Dec 2018
- First submitted
- 22 Jun 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,
- ClinicalTrials.gov ID
- NCT03765905
- Acronym / sponsor ID
- Karadeniz Technical University
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, SCUBE, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Dec 2018 (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 aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index
Detailed description
The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index.
This will be a prospective clinical laboratory study,It will include women with PCOS diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be included in the study group, which will be included in the survey after being approved for participation in the survey from field trials. Forty patients who will not have any complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control group but who had no PCOS o rany other systemic problems and will be similar in terms of age group and body mass index will be included in the study after being approved for participation in the study. From the study and control group, 5 mL of blood will be taken from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1, SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS diagnosis area | – | Diagnostic Test: studyThe study group consisted of 40 reproductive age women between 18th and 35th years old women who were PCOS diagnosis (according to the 2003 Rotherdam criteria) |
| PCOS is not diagnosed | – | Diagnostic Test: studyForty patients who did not have any complaints between the ages of 18-35 who applied to the gynecology policlinic as a control group but who had no PCOS orany other systemic problems and were similar in terms of age group and body mass index were included in the study after being approved for participation in the study |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 women diagnosed with PCOS between the ages of 18-35
Key inclusion criteria (2 listed)
- Clinical diagnosis of PCOS
- 18-35 years old
Key exclusion criteria (8 listed)
- Endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease and congenital adrenal hyperplasia), systemic disease (eg asthma), collagen disorder, hypercholesterolemia, sickle cell anemia or neoplasm,
- Coronary artery disease , angina or myocardial infarction, or any known vascular, infectious, or inflammatory disease, including hypertension, coronary arterioscitis, and electrocardiographic changes;
- Use of any medication (e.g., insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, corticosteroids and gonadotropin releasing hormone agonists and antagonists) within the previous 3 months;
- Abnormal serum albumin concentration (normal concentration, 30-55 g / l),
- Abnormal troponin I concentration,
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 |
|---|---|---|
| studyScube-1 scube-2 scube-3 | Diagnostic test | PCOS diagnosis area, PCOS is not diagnosed |
Primary outcome
Serum SCUBE 1
Time frame: 01.01.2017-31.12.2017
Serum scube1 in microgram
Serum SCUBE 2
Time frame: 01.01.2017-31.12.2017
Serum scube2 in microgram
Serum SCUBE 3
Time frame: 01.01.2017-31.12.2017
Serum scube3 in microgram
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 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Süleyman Güven, Prof principal investigator
Karadeniz TU Medicine Faculty
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 Polycystic Ovary Syndrome, run by Karadeniz Technical 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 2 inclusion and 8 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 Dec 2018. 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 SCUBE 1 (time frame: 01.01.2017-31.12.2017). The study lists 3 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 Dec 2018.