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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

Primary Purpose

Flat Epithelia Atypia, Intraductal Papilloma Without Atypia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pathologic evaluation of excised tissue
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Flat Epithelia Atypia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women all races and ethnic groups are eligible for this trial. This trial is open to the accrual of women only.
  • Patients must be women
  • Patients must be at least 18 years of age
  • Patients must have an imaging abnormality that necessitated a core needle biopsy
  • The imaging abnormality must have been categorized as Breast Imaging-Reporting and Data System (BIRADS) level 1-4 lesion
  • There is documented concordance* between the initial breast imaging finding and the core biopsy pathology report. The core needle biopsy must contain FEA or IPWA, according to the local pathologist. (It is possible that the central pathology review which is done after the patient is registered on this protocol will have a diagnosis discrepant from that made by the original institution's pathologist. In that case, the study team will communicate this to the original institution's site investigator within one week of the date of the central pathology review having been finalized). Patients may have a personal history of prior or concurrent fibroadenoma and a prior history of proliferative breast lesions with or without atypia.
  • Patients must be registered on study within 100 days after core needle biopsy.

  • Patients must have an ability to understand and the willingness to sign a written informed consent document. The patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research.

    • Concordance is a determination by the radiologist (or his or her covering provider) performing an image-guided core needle biopsy that the pathology report from this procedure corresponds to the imaging appearance of a given lesion and that the said lesion's most representative portion has been sampled.

Exclusion Criteria:

  • Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS
  • Palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA
  • Pathologic nipple discharge associated with IPWA (spontaneous bloody or clear persistent single duct discharge)
  • A BIRADS 5 lesion
  • Discordance between the initial breast imaging finding and the core biopsy pathology report
  • The presence of atypical ductal hyperplasia (ADH) on core biopsy
  • Known current pregnancy. A pregnancy test is not required for this exclusion criteria.
  • Women who are breastfeeding
  • Patient registered on study more than 100 days since the date of core needle biopsy.

Sites / Locations

  • University of Alabama at Birmingham
  • Georgetown University
  • MedStar Washington Hospital Center
  • Sibley Memorial Hospital
  • Indiana University
  • MedStar Union Memorial Hospital
  • MedStar Franklin Square Medical Center
  • Johns Hopkins University
  • Howard County General Hospital
  • Dana Farber Cancer Institute
  • Memorial Sloan Kettering Monmouth
  • Memorial SLoan Kettering Bergen
  • Montefiore Medical Center
  • Memorial Sloan Kettering Cancer Center
  • University of North Carolina
  • Duke University
  • University of North Carolina - Hillsborough Campus
  • University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pathologic evaluation of excised tissue

Arm Description

Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). -- Pathologic evaluation of excised tissue

Outcomes

Primary Outcome Measures

Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review

Secondary Outcome Measures

Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review

Full Information

First Posted
June 18, 2015
Last Updated
October 9, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02489617
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Breast milk is made in lobules and is carried through the ducts toward the nipple. Normal ducts are lined by one layer of cells very similar to each other in appearance. Flat epithelia atypia (FEA) and intraductal papilloma without atypia (IPWA) are changes seen within the milk ducts. In the recent years these lesions have been seen more often, seemingly because more core needle biopsies are being done with the help of a mammogram, ultrasound or breast MRI. The reason for this is there is new technology available which is able to do such biopsies. A core needle biopsy uses a hollow needle to remove samples of tissue from the breast. This is an accurate method that does not involve surgery. FEA and IPWA are not very common and there are few research studies addressing them. Women found to have FEA or IPWA on core biopsy results may receive conflicting recommendations about how to precede next. It is unclear if more tissue should be removed from the biopsy site to ensure that there is no cancer nearby. The purpose of this study is to find out how often cancer is identified by excisional biopsy near an initial core biopsy where FEA or IPWA has previously been seen. Depending on these findings doctors will be better able to advise their patients as to whether they need to have a surgical biopsy, when FEA or IPWA are seen on needle biopsy, to rule out the presence of breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flat Epithelia Atypia, Intraductal Papilloma Without Atypia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pathologic evaluation of excised tissue
Arm Type
Experimental
Arm Description
Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). -- Pathologic evaluation of excised tissue
Intervention Type
Other
Intervention Name(s)
Pathologic evaluation of excised tissue
Intervention Description
Up to 3 months after excisional biopsy
Primary Outcome Measure Information:
Title
Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review
Time Frame
60 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women all races and ethnic groups are eligible for this trial. This trial is open to the accrual of women only. Patients must be women Patients must be at least 18 years of age Patients must have an imaging abnormality that necessitated a core needle biopsy The imaging abnormality must have been categorized as Breast Imaging-Reporting and Data System (BIRADS) level 1-4 lesion There is documented concordance* between the initial breast imaging finding and the core biopsy pathology report. The core needle biopsy must contain FEA or IPWA, according to the local pathologist. (It is possible that the central pathology review which is done after the patient is registered on this protocol will have a diagnosis discrepant from that made by the original institution's pathologist. In that case, the study team will communicate this to the original institution's site investigator within one week of the date of the central pathology review having been finalized). Patients may have a personal history of prior or concurrent fibroadenoma and a prior history of proliferative breast lesions with or without atypia. Patients must be registered on study within 100 days after core needle biopsy. Patients must have an ability to understand and the willingness to sign a written informed consent document. The patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research. Concordance is a determination by the radiologist (or his or her covering provider) performing an image-guided core needle biopsy that the pathology report from this procedure corresponds to the imaging appearance of a given lesion and that the said lesion's most representative portion has been sampled. Exclusion Criteria: Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS Palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA Pathologic nipple discharge associated with IPWA (spontaneous bloody or clear persistent single duct discharge) A BIRADS 5 lesion Discordance between the initial breast imaging finding and the core biopsy pathology report The presence of atypical ductal hyperplasia (ADH) on core biopsy Known current pregnancy. A pregnancy test is not required for this exclusion criteria. Women who are breastfeeding Patient registered on study more than 100 days since the date of core needle biopsy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faina Nakhlis, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
MedStar Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
MedStar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Howard County General Hospital
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial SLoan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of North Carolina - Hillsborough Campus
City
Hillsborough
State/Province
North Carolina
ZIP/Postal Code
27278
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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