Study Into Treatment of Hyperplasia of Mammary Glands

Shandong University

Status

Unknown

Conditions

Hyperplasia

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02505256

BEST P-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5,000 estimated patients

Sex

Female

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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.