Breast DiseasesNCT04231786
Breast Ultrasonography and Polycystic Ovary Syndrome
An observational study of Breast Diseases and Polycystic Ovary, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The results of the evaluation of breast ultrasonography results of patients with polycystic ovary syndrome diagnosis over 30 years of age will be evaluated. Patients admitted to the outpatient clinic and rotterdam criteria according to laboratory data and polycystic ovary syndrome patients diagnosed by the same… Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Breast Diseases, Polycystic Ovary
- What is being tested?
- Breast ultrasonography findings
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2020to 14 Jul 2020
- How long will I take part?
- 1 Month
- 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 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: patients over 30 years of age diagnosed with polycystic ovary syndrome breast ultrasonography findings in these patients
Who may be able to join
- Over 30 years
- diagnosed with polycystic ovary syndrome according to rotterdam criteria
- no previous history of breast disease
- female patients
Who cannot join
- Under 30 years
- polycystic ovary syndrome
- patients with a previously known history of breast disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Breast Ultrasonography Findings in Patients Over 30 Years With Polycystic Ovary Syndrome
The results of the evaluation of breast ultrasonography results of patients with polycystic ovary syndrome diagnosis over 30 years of age will be evaluated.
Patients admitted to the outpatient clinic and rotterdam criteria according to laboratory data and polycystic ovary syndrome patients diagnosed by the same radiologist the next day after the end of menstrual breast ultrasonography. The aim of this study is to show the association of polycystic ovary syndrome and fibrocystic breast.
- Conditions
- Breast Diseases, Polycystic Ovary
- Being tested
- Breast ultrasonography findings
- Keywords
- breast diseases, fibrocystic breast, polycystic ovari syndrome, fibroadenoma
- Medical subject headings
- Breast Diseases, Polycystic Ovary Syndrome, Cystic Fibrosis, Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast ultrasonography findingsProcedure or surgery
Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast ultrasonography findings
Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome. THE PRESENCE OF FIBROCISTIC DISEASE WILL BE EVALUATED FOR FIBROADENOMA OR OTHER BREAST DISEASE. YES OR NO ; WILL BE REGISTERED.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start14 Jan 2020
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231786
- Sponsor's protocol ID
- 2019.05.122
- Status last verified
- Sep 2020
- First submitted
- 14 Jan 2020
- Last updated
- 3 Sep 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 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Ultrasonography Findings in Patients Over 30 Years With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04231786
- Acronym / sponsor ID
- 2019.05.122
- Conditions
- Breast Diseases, Polycystic Ovary
- Keywords
- breast diseases, fibrocystic breast, polycystic ovari syndrome, fibroadenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 18 Jan 2020 (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 results of the evaluation of breast ultrasonography results of patients with polycystic ovary syndrome diagnosis over 30 years of age will be evaluated.
Patients admitted to the outpatient clinic and rotterdam criteria according to laboratory data and polycystic ovary syndrome patients diagnosed by the same radiologist the next day after the end of menstrual breast ultrasonography. The aim of this study is to show the association of polycystic ovary syndrome and fibrocystic breast.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients over 30 years of age diagnosed with polycystic ovary syndrome breast ultrasonography findings in these patients
Key inclusion criteria (4 listed)
- Over 30 years
- diagnosed with polycystic ovary syndrome according to rotterdam criteria
- no previous history of breast disease
- female patients
Key exclusion criteria (3 listed)
- Under 30 years
- polycystic ovary syndrome
- patients with a previously known history of breast 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 |
|---|---|---|
| Breast ultrasonography findingsBreast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome. | Procedure or surgery | – |
Primary outcome
Breast ultrasonography findings
Time frame: 1 month
Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome. THE PRESENCE OF FIBROCISTIC DISEASE WILL BE EVALUATED FOR FIBROADENOMA OR OTHER BREAST DISEASE. YES OR NO ; WILL BE REGISTERED.
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 3 Sep 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 Breast Diseases and Polycystic Ovary, run by Kanuni Sultan Suleyman Training and Research Hospital 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 4 inclusion and 3 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 3 Sep 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?
Breast ultrasonography findings (time frame: 1 month). 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 3 Sep 2020.