CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study
March 21, 2023 updated by: Chen-Pin Chou, Kaohsiung Veterans General Hospital.
To evaluate the effectiveness of Contrast-enhanced digital mammography (CEDM) in detecting breast cancer in women at higher risk.
Study Overview
Detailed Description
The aim of this study was to evaluate the effectiveness of different imaging techniques for detecting breast cancer in women with a higher risk due to personal or family history of the disease.
Study Type
Observational
Enrollment (Actual)
351
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
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Kaohsiung, Taiwan, 813
- Kaohsiung Veterans General Hospital
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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
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women underwent CEDM screening at Kaohsiung Veterans General Hospital from January 2019 to December 2021
Description
Inclusion Criteria:
- women underwent CEDM screening
Exclusion Criteria:
- incomplete imaging exams
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total number of cases received and diagnosed with breast cancer (Number)
Time Frame: Up to 3 years
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This refers to the total number of individuals who underwent breast cancer screening or assessment and the number diagnosed with breast cancer.
Evaluating the accuracy of screening tests using measures such as true positives and true negatives is crucial for assessing the reliability of screening tests and identifying potential issues.
These measures help healthcare professionals make informed decisions about screening and diagnostic strategies.
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number)
Time Frame: Up to 3 years
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This refers to the total number of individuals who underwent breast cancer screening or assessment and tested positive, requiring a biopsy and MRI for further evaluation.
A biopsy is necessary to confirm whether an individual has breast cancer.
Monitoring the diagnostic accuracy of breast cancer screening tests and the number of individuals requiring further procedures is essential for determining appropriate treatment or monitoring.
Measures such as true positives and true negatives are used to evaluate the accuracy of screening tests.
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Up to 3 years
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True positive results obtained by the diagnostic method (Number)
Time Frame: Up to 3 years
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The total number of true positive results obtained by the diagnostic method, indicating the cases with breast cancer that are correctly identified.
A higher number of true positives demonstrates better performance in correctly identifying cases with breast cancer.
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Up to 3 years
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True negative results obtained by the diagnostic method (Number)
Time Frame: Up to 3 years
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The total number of true negative results obtained by the diagnostic method, indicating the cases without breast cancer that are correctly identified.
A higher number of true negatives demonstrates better performance in correctly identifying cases without breast cancer and reducing false positives.
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Up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
March 8, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGHKS18-CT11-17
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.