The Effect of Digital Breast Tomosynthesis in Breast Canc... | NCT05600257

Studies
The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study

NCT05600257

Sponsor

Kaohsiung Veterans General Hospital.

Status

Completed

Last Update Posted

Nov 4, 2022Actual

Enrollment

1,517Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Countries

Taiwan

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

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2011Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Aug 31, 2021Actual

First Submitted Date

Oct 26, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 31, 2022Actual

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

Nov 1, 2022

Last Update Posted Date

Nov 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen-Pin Chou, Radiologist, Kaohsiung Veterans General Hospital.Principal Investigator

Lead Sponsor

Kaohsiung Veterans General Hospital.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.

Detailed Description

To suggest DBT for specific populations, compare the overall survival rate of women with digital mammography (DM) to the DBT screening for women with particular characteristics.

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

No data available

No data is available for this block.

Enrollment

1,517Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Screening cohort		Women received mammography screening	Device: DBT Device: DM
Diagnostic cohort		Women received clinical breast examination	Device: DBT Device: DM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DBT	Device	Image with digital breast tomosynthesis	Diagnostic cohort Screening cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival rate	Compare the overall survival rate according to breast density type, cancer stage, mammography test type, and imaging modality.	Up to 111 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

individuals were diagnosed with breast cancer according to the International Disease Classification Criteria

Exclusion Criteria:

no surgery or incomplete surgical pathology stage
complete remission after neoadjuvant chemotherapy
non-breast cancer death
bilateral breast cancer
male breast cancer
no pre-surgery mammography image

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals were diagnosed with breast cancer according to the International Disease Classification Criteria from September 2011 to December 2015.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chen-Pin Chou, MD	Kaohsiung Veterans General Hospital.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Veterans General Hospital		Kaohsiung City		813	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

The data that support the findings of this study are available on reasonable request from the corresponding author. Some data are not publicly available due to their containing information that could compromise the privacy of research participants.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008327	Mammography

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided