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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| ClinicalTrials.gov Identifier: NCT02489617 |
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Recruitment Status :
Active, not recruiting
First Posted : July 3, 2015
Last Update Posted : April 17, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Flat Epithelia Atypia Intraductal Papilloma Without Atypia | Other: Pathologic evaluation of excised tissue | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 246 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | September 2015 |
| Actual Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pathologic evaluation of excised tissue
Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). -- Pathologic evaluation of excised tissue |
Other: Pathologic evaluation of excised tissue
Up to 3 months after excisional biopsy |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489617
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| Principal Investigator: | Faina Nakhlis, MD | Dana-Farber Cancer Institute |
| Responsible Party: | Faina Nakhlis, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT02489617 |
| Other Study ID Numbers: |
15-174 |
| First Posted: | July 3, 2015 Key Record Dates |
| Last Update Posted: | April 17, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Papilloma Papilloma, Intraductal Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Squamous Cell Neoplasms, Ductal, Lobular, and Medullary |