NCT04231786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

January 14, 2020

Last Update Submit

September 2, 2020

Conditions

Keywords

breast diseasesfibrocystic breastpolycystic ovari syndromefibroadenoma

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome.

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast DiseasesPolycystic Ovary SyndromeCystic FibrosisFibroadenoma

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesNeoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

January 14, 2020

Primary Completion

July 14, 2020

Study Completion

July 14, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations