NCT02505256

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

2.7 years

First QC Date

July 18, 2015

Last Update Submit

July 21, 2015

Conditions

Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands

    8 months

Secondary Outcomes (1)

  • Clinical manifestations as an surgical indications for hyperplasia of mammary glands

    8 months

Study Arms (1)

case group

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

Other: No intervention

Interventions

No interventionOTHER
case group

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females who reported breast pain of breast lumps.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Hospital of Shandong Universtity

Jinan, Shandong, 250033, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

breast tissues

MeSH Terms

Conditions

Hyperplasia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gang Z Yu, PhD，MD

    The Second Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Z Yu, PhD, MD

CONTACT

+13864182636yzg@medmail.com.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Breast Surgery

Study Record Dates

First Submitted

July 18, 2015

First Posted

July 22, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

CN(1)