Clinical Trial: NCT02489617 - My Cancer Genome

NCT02489617

Description:

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.

Related Conditions:

Flat Ductal Epithelial Atypia of the Breast
Intraductal Breast Papilloma

Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02489617

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 15-174
NCT ID: NCT02489617

Conditions

Flat Epithelia Atypia
Intraductal Papilloma Without Atypia

Purpose

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.

Trial Arms

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

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.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	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
Safety Issue:
Description:

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Dana-Farber Cancer Institute

Last Updated

July 16, 2021

Clinical Trials /

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