Study Into Treatment of Hyperplasia of Mammary Glands

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.

Study Overview

• Status: Unknown
• Conditions: Hyperplasia
• Intervention / Treatment: Other: No intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Gang Z Yu, PhD, MD; Phone Number: +13864182636; Email: yzg@medmail.com.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250033
      • Recruiting
      • the Second Hospital of Shandong Universtity
      • Contact: Gang Z Yu, Dr; PhD; Phone Number: +86 0531-85875048; Email: yzg@medmail.com.cn
      • Principal Investigator: Gang Z Yu, Dr; PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females who reported breast pain of breast lumps.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case group; cases who presented as breast pain or breast lumps, and no intervention will be administered.	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands	8 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical manifestations as an surgical indications for hyperplasia of mammary glands	8 months

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Gang Z Yu, PhD，MD, The Second Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 18, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: BEST P-01