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

Completed

• Conditions: Breast Cancer
• Interventions: Device: DBT; Device: DM

• Registration Number: NCT05600257
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

Study Timeline

• Study Start: 2011-09-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1517

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening cohort	DM	Women received mammography screening
Screening cohort	DBT	Women received mammography screening
Diagnostic cohort	DBT	Women received clinical breast examination
Diagnostic cohort	DM	Women received clinical breast examination

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan