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 on Cancer Detection Rates in Excisional Biopsy

Recruiting
18 years - 100 years
Female
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

The purpose of this study is to find out how often cancer is identified by excisional biopsy near an initial core biopsy where flat epithelia atypia or intraductal papilloma without atypia has previously been seen.

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: flat epithelia atypia,intraductal papilloma without atypia,Adjacent Synchronous Ipsilateral Infiltrating Carcinoma,Intraductal Papilloma,papilloma,invasive breast cancer,breast cancer,cancer,oncology
  • Age: 18 years - 100 years
  • Gender: Female

Inclusion Criteria
Must have an imaging abnormality that necessitated a core needle biopsy
Patients must be registered on study within 60 days after core needle biopsy
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
A BIRADS 5 lesion
Discordance between the initial breast imaging finding and the core biopsy pathology report
The presence of atypical ductal hyperplasia on core biopsy
Known current pregnancy
Women who are breastfeeding
Patient registered on study more than 60 days since the date of core needle biopsy

Updated on 19 Feb 2024. Study ID: 1601641454 (TBCRC034)

This study investigates how often cancer is found when an excisional biopsy is done near an initial core biopsy. The initial core biopsy showed flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA). Flat epithelial atypia is a condition where the cells lining the milk ducts of the breast look abnormal under a microscope, but are not cancer. Intraductal papilloma without atypia is a small, non-cancerous tumor that grows in a milk duct of the breast.

Participants in this study will undergo an excisional biopsy procedure. This means a small area of tissue will be removed for closer examination. The study will help determine how often cancer is detected in these cases. Participants will not receive any payment for joining the study.

  • Who can participate: Individuals with an imaging abnormality requiring a core needle biopsy may participate. Participants must be registered within 60 days after the core needle biopsy. Those with a history of invasive breast cancer, palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA, pathologic nipple discharge associated with IPWA, a BIRADS 5 lesion, discordance between the initial breast imaging finding and the core biopsy pathology report, the presence of atypical ductal hyperplasia on core biopsy, or current pregnancy are excluded. Women who are breastfeeding are also excluded.
  • Study details: Participants will have an excisional biopsy, which involves removing a small piece of tissue for examination. This study does not involve any investigational medications or placebos. Participants will not receive any payment for participating in the study.

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