Breast Ultrasonography and Polycystic Ovary Syndrome | NCT04231786

Studies
Breast Ultrasonography and Polycystic Ovary Syndrome

NCT04231786

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Sep 3, 2020Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Breast Diseases
Polycystic Ovary

Interventions

Breast ultrasonography findings

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2020Actual

Primary Completion Date

Jul 14, 2020Actual

Completion Date

Jul 14, 2020Actual

First Submitted Date

Jan 14, 2020

First Submission Date that Met QC Criteria

Jan 14, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2020

Last Update Posted Date

Sep 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pınar Kadirogulları, Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast ultrasonography findings	Procedure	Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 30 years
diagnosed with polycystic ovary syndrome according to rotterdam criteria
no previous history of breast disease
female patients

Exclusion Criteria:

Under 30 years
polycystic ovary syndrome
patients with a previously known history of breast disease

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

patients over 30 years of age diagnosed with polycystic ovary syndrome breast ultrasonography findings in these patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Süleyman Training and Research Hospital		Istanbul		33404	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D001941	Breast Diseases
D011085	Polycystic Ovary Syndrome
D003550	Cystic Fibrosis
D018226	Fibroadenoma

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D010048	Ovarian Cysts
D003560	Cysts

Browse Leaves

Not provided

Browse Branches

Not provided