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Status unknownNCT02505256Updated Jul 22, 2015

Study Into Treatment of Hyperplasia of Mammary Glands

An observational study in Hyperplasia, sponsored by Shandong University. Status unknown at 1 site in China. Open to female participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-22.

Sponsored by Shandong University · Observational

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
5,000
Ages
25 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperplasia

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03

In context

Hyperplasia

891 studies on the registry are indexed under Hyperplasia; 103 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 157 across 238 observational studies indexed under Hyperplasia.

Browse Hyperplasia studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Females who reported breast pain of breast lumps.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • case group

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

    Other: No intervention

Interventions

  • OtherNo intervention
06

What researchers measure

Primary outcomes

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

    Time frame: 8 months

Secondary outcomes

  1. Clinical manifestations as an surgical indications for hyperplasia of mammary glands

    Time frame: 8 months

07

Study locations

1 of 1 sites recruiting
  • the Second Hospital of Shandong Universtity
    Jinan, Shandong 250033, China
    • Gang Z Yu, Dr; PhD · Contact · yzg@medmail.com.cn · +86 0531-85875048
    • Gang Z Yu, Dr; PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02505256
Lead sponsor
Shandong University
Responsible party
Yu-Zhi Gang (Chief of Department of Breast Surgery, Shandong University) — Principal investigator
First posted
Jul 22, 2015
Start date
Apr 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jul 22, 2015

Study contacts

Gang Z Yu, PhD, MD
Contact
yzg@medmail.com.cn
+13864182636
Gang Z Yu, PhD，MD
principal investigator · The Second Hospital of Shandong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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