X-Ray Mammography Standard of Care Protocol
Condition: Breast Cancer; Invasive Carcinoma; In Situ Carcinoma; Fibrocystic Changes; Atypical Ductal Hyperplasia
MeSH terms: Carcinoma; Carcinoma, Intraductal, Noninfiltrating; Hyperplasia
Study type: Observational

Summary: 
      Background:

        -  X-ray mammography is the standard method for breast cancer screening. It is a
           noninvasive test using x-rays to take pictures of breast tissue and detect any
           abnormalities.

        -  The National Institutes of Health (NIH) Clinical Center has a breast imaging unit that
           has been accredited by the American College of Radiology. To maintain accreditation, the
           unit must recruit a certain number of women to have clinical mammograms each year in
           order to maintain a high level of clinical skills and experience for the radiologists
           and technologists.

      Objectives:

      - To create a state-of-the-art mammography unit at the NIH Clinical Center in order to
      maintain American College of Radiology accreditation of the NIH breast imaging facility.

      Eligibility:

      - Women who are eligible for breast cancer screening because of family cancer history,
      genetic test results, or previous instances of cancer. Participants may not be pregnant or
      nursing at the time of the screening.

      Design:

        -  Participants will provide a brief medical history on arrival at the NIH breast imaging
           unit.

        -  Each participant will have a standard mammogram performed by a radiology technician.

        -  If the study is normal, participants will be told that no further evaluation will be
           performed. If the results indicate a need for further imaging or tissue biopsy,
           participants may elect to return to the care of their primary physician or to receive
           further follow-up at the NIH Clinical Center.
    

Detailed description: 
      Background:

      A mammography facility in the Clinical Center of the National Institutes of Health (NIH) is
      present in order to facilitate breast cancer research programs. The American College of
      Radiology mammography accreditation program (1992 mammography Quality Standards Act (MQSA)
      (1-3)) has established national standards for site accreditation for mammography. A key
      requirement is to perform a minimum number of mammography examinations in the facility per
      year. Minimum examination volumes are required to maintain expertise of the facility staff
      for maintaining facility accreditation and compliance with Food and Drug Administration (FDA)
      requirements.

      Objectives:

      Our primary aim is a protocol to maintain accreditation of the NIH breast imaging facility in
      the Clinical Center of NIH.

      Eligibility:

      Women who are clinically indicated for screening mammography according to the National
      Comprehensive Cancer Network (NCCN) guidelines (3) and the American Cancer Society
      guidelines.

      Design:

      A standard of care protocol to perform standard clinically indicated mammography exams. We
      are expected to recruit 1000 patient /year.
    

Time perspective: Prospective
Keywords: Breast Cancer; Mammography; Screening