Study Into Treatment of Hyperplasia of Mammary Glands

• Sponsor: Shandong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02505256
• Collaborator: (none)
• Enrollment: 5,000
• Location: 1
• Duration (Months): 44
• Patients Per Site Per Month: 113.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperplasia	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 Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Study Into Treatment of Hyperplasia of Mammary Glands
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands [8 months]

Secondary Outcome Measures

1. Clinical manifestations as an surgical indications for hyperplasia of mammary glands [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Second Hospital of Shandong Universtity	Jinan	Shandong	China	250033

Sponsors and Collaborators

• Shandong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yu-Zhi Gang, Chief of Department of Breast Surgery, Shandong University
• ClinicalTrials.gov Identifier: NCT02505256
• Other Study ID Numbers: BEST P-01
• First Posted: Jul 22, 2015
• Last Update Posted: Jul 22, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Hyperplasia

Study Results

No Results Posted as of Jul 22, 2015