Clinical trial · Interventional
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
NCT02489617CI-TRIAL-00096316completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Flat Epithelia Atypia | — | UNRESOLVED | — |
| Intraductal Papilloma Without Atypia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pathologic evaluation of excised tissue | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pathologic evaluation of excised tissue
- description
- Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). \-- Pathologic evaluation of excised tissue
- interventionNames
- Other: Pathologic evaluation of excised tissue
Primary outcomes (1)
- measure
- Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review
- timeFrame
- 60 days
Secondary outcomes (1)
- measure
- Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review
- timeFrame
- 60 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.