Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy
The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS, or Atypical Ductal Hyperplasia (ADH) in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy
1 other identifier
observational
78
1 country
2
Brief Summary
The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2004
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMarch 31, 2017
November 1, 2012
8 years
September 2, 2005
March 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy
Concomittant
Secondary Outcomes (1)
Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ
Eligibility Criteria
Individuals who have ALH/LCIS detected on a needle biospy of the breast
You may qualify if:
- Women 20 years of age or older
- Imaging abnormality necessitating a core needle biopsy
- Core needle biopsy revealing ALH or LCIS
- Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia
You may not qualify if:
- History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
- A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
- Received tamoxifen in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Translational Breast Cancer Research Consortiumcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (2)
Dana-Farber Cancer Center
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Biospecimen
Option of keeping tissue sample for further research
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Faina Nakhlis, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor in Surgery, Harvard Medical School
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
November 1, 2004
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
March 31, 2017
Record last verified: 2012-11