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

November 1, 2022 updated by: Chen-Pin Chou, Kaohsiung Veterans General Hospital.
To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening cohort
Women received mammography screening
Device: DBT
Image with digital breast tomosynthesis
Other Names:
  • Digital Breast Tomosynthesis
Device: DM
Image with digital mammography
Other Names:
  • Digital Mammography
Diagnostic cohort
Women received clinical breast examination
Device: DBT
Image with digital breast tomosynthesis
Other Names:
  • Digital Breast Tomosynthesis
Device: DM
Image with digital mammography
Other Names:
  • Digital Mammography

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Chen-Pin Chou, MD, Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSVGH22-CT11-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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