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Multiple endocrine neoplasia type 2 |
MEN 2; MEN II |
Clinical Trial: Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS or ADH in Patients with Lobular Neoplasia of the Breast
This study is currently recruiting patients.
Verified by Dana-Farber Cancer Institute September 2005
Purpose
The goal of this study is to determine how often patients who have ALH or 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.
| Condition | Intervention |
|---|---|
| Lobular neoplasia of the breast | Procedure: Surgical Biopsy |
MedlinePlus consumer health information
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title: 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
Further Study Details:
Expected Total Enrollment: 78
Study start: November 2004
Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast.
- The surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed.
- In the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. The tissue will be kept for future research for up to 10 years.
Eligibility
Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History and/or concomitant diagnosis of invasive breast cancer or DCIS
- Past history of ALH or LCIS
- A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
- Received tamoxifen in the past
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00146536
Faina Nakhlis, MD 617-632-5178 faina_nakhlis@dfci.harvard.edu
Massachusetts
Dana-Farber Cancer Center, Boston, Massachusetts, 02115, United States; Recruiting
Faina Nakhlis, MD, Principal Investigator
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Stuart J. Schnitt, MD, Principal Investigator
Study chairs or principal investigators
Faina Nakhlis, MD, Principal Investigator, Dana-Farber Cancer Institute
More Information
Study ID Numbers: 04-164
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00146536
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00146536
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Multiple endocrine neoplasia type 2 (Genetics Home Reference)
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