Study Into Treatment of Hyperplasia of Mammary Glands | NCT02505256

Studies
Study Into Treatment of Hyperplasia of Mammary Glands

NCT02505256

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Jul 22, 2015Estimated

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Hyperplasia

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 18, 2015

First Submission Date that Met QC Criteria

Jul 21, 2015

First Posted Date

Jul 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2015

Last Update Posted Date

Jul 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yu-Zhi Gang, Chief of Department of Breast Surgery, Shandong UniversityPrincipal Investigator

Lead Sponsor

Shandong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case group		cases who presented as breast pain or breast lumps, and no intervention will be administered.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		case group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Females who reported breast pain of breast lumps.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gang Z Yu, PhD, MD	Contact	+13864182636		yzg@medmail.com.cn

Overall Officials

Name	Affiliation	Role
Gang Z Yu, PhD，MD	The Second Hospital of Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Second Hospital of Shandong Universtity	Recruiting	Jinan	Shandong	250033	China

Condition Browse Module

MeSH Terms

ID	Term
D006965	Hyperplasia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided