Study Into Treatment of Hyperplasia of Mammary Glands

Hyperplasia Clinical Trial

Official title:

Study Into Treatment of Hyperplasia of Mammary Glands

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02505256
• Other study ID #: BEST P-01
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2015
• Last updated: July 21, 2015
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2015
• Source: Shandong University
• Contact: Gang Z Yu, PhD, MD
• Phone: +13864182636
• Email: yzg[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperplasia

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
China	the Second Hospital of Shandong Universtity	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands		8 months	No
Secondary	Clinical manifestations as an surgical indications for hyperplasia of mammary glands		8 months	No