Study Into Treatment of Hyperplasia of Mammary Glands

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

Brief Summary

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Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline for the treatment of this disease. This study was launched to investigate into the problem that which patients should be diagnosed as hyperplasia of mammary glands and which patients should be treated.

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Detailed Description

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Females who meet the inclusion criteria will receive breast ultrasonography, mammography and pathological examinations by core needle biopsy. All participants will receive a follow-up at an 6-month interval for 2 years. During the follow-up period, whether the symptoms relieve will be evaluated.

Conditions

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Hyperplasia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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case group

cases who presented as breast pain or breast lumps, and no intervention will be administered.

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Reported breast pain or breast lumps.
* Willing to be kept follow-up.
* Functions below are maintained in major organs: liver, renal and heart.
* Written informed consent will be obtained for patients for entering this study.

Exclusion Criteria

* Typical breast cancer or fibroadenoma.
* Classification by breast ultrasonography of mammography is beyond Breast Imaging - Reporting And Data System (BI-RADS) 4.
* Oral contraceptive or hormone replacement therapy.
* History of breast cancer or other malignancies.
* History of pituitary gland disease.
* Potentially pregnant, pregnant, or breast-feeding.

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No