A Comparative Study of Mammography and Ultrasound for Bre... | NCT04429269

Studies
A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis

NCT04429269

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Jul 9, 2020Actual

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Breast Cancer Diagnosis
Breast Cancer Screening

Interventions

mammography and ultrasound screening

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 2020

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

Jun 12, 2020Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Jun 10, 2020

First Submission Date that Met QC Criteria

Jun 10, 2020

First Posted Date

Jun 12, 2020Actual

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 7, 2020

Last Update Posted Date

Jul 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Detailed Description

Breast cancer has become the most common malignancy in women. Improving the early diagnosis of breast cancer can reduce mortality. Mammography is recommended as the main tool for screening and early diagnosis of breast cancer in the guidelines of European and American countries. However, the characteristics of dense breast and young onset of disease in Chinese women make the screening and early diagnosis strategies of Western countries, which are mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

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

6,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mammography and ultrasound		mammography and ultrasound screening	Diagnostic Test: mammography and ultrasound screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mammography and ultrasound screening	Diagnostic Test	Patients screened by both mammography and ultrasound.	mammography and ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
screening yield	The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.	3 years

Secondary Outcomes

Measure	Description	Time Frame
cost-effectiveness	The cost-effectiveness of each screening modality to detect one case of breast cancer	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray

Exclusion Criteria:

Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo ultrasound and X-rays

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Songjie Shen, MD	Contact	(010) 6915 8721		shensj@pumch.cn

Overall Officials

Name	Affiliation	Role
Songjie Shen, MD	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Recruiting	Beijing	Beijing Municipality	100730	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39715848	Derived	Wang Y, Li Y, Qu Y, Zhou Y, Sun Q, Shen S. Clinical and imaging characteristics of intraductal papillary neoplasms of the breast: a prospective trial. Discov Oncol. 2024 Dec 23;15(1):831. doi: 10.1007/s12672-024-01681-y.
36177910	Derived	Wang Y, Li Y, Song Y, Chen C, Wang Z, Li L, Liu M, Liu G, Xu Y, Zhou Y, Sun Q, Shen S. Comparison of ultrasound and mammography for early diagnosis of breast cancer among Chinese women with suspected breast lesions: A prospective trial. Thorac Cancer. 2022 Nov;13(22):3145-3151. doi: 10.1111/1759-7714.14666. Epub 2022 Sep 30.

ID	Term
D001943	Breast Neoplasms
D004194	Disease

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis