FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS | NCT04259866

Studies
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS

NCT04259866

Sponsor

"G Criscuoli" Hospital

Status

Completed

Last Update Posted

Feb 7, 2020Actual

Enrollment

4,500Actual

Phase

Not provided

Conditions

Breast Cancer Screening

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 1, 2020Actual

First Submitted Date

Feb 5, 2020

First Submission Date that Met QC Criteria

Feb 5, 2020

First Posted Date

Feb 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2020

Last Update Posted Date

Feb 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Graziella Di Grezia, 1st level Assistant Physician, Azienda Sanitaria ASL Avellino 2Principal Investigator

Lead Sponsor

"G Criscuoli" HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,500Actual

Measure	Description	Time Frame
recall rate		15 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breast cancer screening population

Exclusion Criteria:

previous cancer
breast prostheses

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

female population candidated to breast cancer screening program

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graziella Di Grezia		Avellino	Av	83100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided