NCT04259866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 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

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 5, 2020

Last Update Submit

February 5, 2020

Conditions

Breast Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • recall rate

    15 days

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female population candidated to breast cancer screening program

You may qualify if:

  • breast cancer screening population

You may not qualify if:

  • previous cancer
  • breast prostheses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graziella Di Grezia

Avellino, Av, 83100, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
1st level Assistant Physician

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

IT(1)