NCT04926688

Brief Summary

In this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided CNB/VAB, and evaluate the clinical, imaging and histologic features for associated malignancy risk. The possibility of upgrade related to histologic subtype, tissue sampling and other variables was also evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

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

June 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

June 10, 2021

Last Update Submit

April 26, 2022

Conditions

Premalignant Lesion

Outcome Measures

Primary Outcomes (1)

  • upgrade rates related to histologic subtype, tissue sampling and other variables

    the results from excisional biopsy or at least 1 year follow-up documentation

    one year

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied

You may qualify if:

  • Image guided needle biopsy diagnosis
  • Atypical ductal hyperplasia
  • Lobular neoplasia
  • Flat epithelial atypia
  • Papilloma
  • Radial scar
  • Diagnosed on image guided needle biopsy

You may not qualify if:

  • Fibroepithelial tumors
  • Mucocele like tumors
  • Diagnosed on surgical biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

Study Officials

  • Aysenur Oktay, MD

    Ege University

    STUDY CHAIR

  • Ozge Aslan, MD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 15, 2021

Study Start

June 10, 2020

Primary Completion

January 20, 2021

Study Completion

June 10, 2021

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

After finishing statistical analysis the results will be published

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
3 months
Access Criteria
after publication

Locations

TU(1)