- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04259866
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS
February 5, 2020 updated by: Graziella Di Grezia, "G Criscuoli" Hospital
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS: An Analysis of Findings Leading to Recall and Work-up in ASL Avellino Screening
To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images.
This study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
4500
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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Av
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Avellino, Av, Italy, 83100
- Graziella Di Grezia
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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
50 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
female population candidated to breast cancer screening program
Description
Inclusion Criteria:
- breast cancer screening population
Exclusion Criteria:
- previous cancer
- breast prostheses
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 |
Time Frame |
---|---|
recall rate
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
February 5, 2020
First Submitted That Met QC Criteria
February 5, 2020
First Posted (Actual)
February 7, 2020
Study Record Updates
Last Update Posted (Actual)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05022020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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