NCT05600257

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2011

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

10 years

First QC Date

October 26, 2022

Last Update Submit

November 1, 2022

Conditions

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Screening cohort

Women received mammography screening

Device: DBTDevice: DM

Diagnostic cohort

Women received clinical breast examination

Device: DBTDevice: DM

Interventions

DBTDEVICE

Image with digital breast tomosynthesis

Also known as: Digital Breast Tomosynthesis
Diagnostic cohortScreening cohort
DMDEVICE

Image with digital mammography

Also known as: Digital Mammography
Diagnostic cohortScreening cohort

Eligibility Criteria

Age23 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Chen-Pin Chou, MD

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

September 1, 2011

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

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.

Locations