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The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed With Intraductal Papilloma Without Atypia or Flat Epithelial Atypia by Core Needle Biopsy

NCT02489617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-10-06

No results posted yet for this study

Summary

This research study is studying a surgical intervention to rule out the presence of cancer in participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy.

Conditions

  • Flat Epithelia Atypia
  • Intraductal Papilloma Without Atypia

Interventions

OTHER

Pathologic evaluation of excised tissue

Up to 3 months after excisional biopsy

Sponsors & Collaborators

Principal Investigators

  • Faina Nakhlis, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2021-12-31
Completion
2025-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489617 on ClinicalTrials.gov