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X-Ray Mammography Standard of Care Protocol


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Invasive Carcinoma, In Situ Carcinoma, Fibrocystic Changes, Atypical Ductal Hyperplasia

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Trial Information

X-Ray Mammography Standard of Care Protocol


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.

Inclusion Criteria


- INCLUSION CRITERIA:

Women who are clinically indicated for screening mammography according to the National
Comprehensive Cancer Network (NCCN) guidelines (3) and the American Cancer Society
guidelines:

1. All women who fall under the ACS mammography guidelines

2. Women younger than 40 years but with more than 20% lifetime risk for developing
breast cancer:

1. Prior personal history of prior thoracic radiation therapy between the age of 10
and 30, such as for Hodgkin's disease. In this case, women are eligible
beginning 8-10 years after radiotherapy or at age 40, whichever comes first.

2. 5-year risk of invasive breast cancer (greater than or equal to 1.7% of women
greater than or equal to 35 years or women who have a life time risk greater
than 20% as defined by models that are largely dependent on family history.

3. Strong family history;

i. First degree relative diagnosed with breast, ovarian, fallopian tube, or primary
peritoneal cancer.

ii. Individual from families known to have BRCA 1 or 2 gene mutation.

iii. Close male blood relative with breast cancer.

d. Genetic predisposition;

i. Carry or have first-degree relative who carries a genetic mutation in the BRCA 1
or 2 genes.

ii. Carry or have a first-degree relative who carries a genetic mutation in the TP53
or PTEN genes (Li-Fraumeni syndrome and Cowden Bannayan-Riley-Ruvalcaba syndromes).

e. A personal history of Lobular carcinoma in situ (LCIS) and/or atypical ductal
hyperplasia (ADH)

f. Prior personal history of breast cancer or ovarian cancer.

i. Starting at the age of 25 year for Hereditary breast and ovarian cancer patients.

ii. 5-10 years prior to youngest breast cancer case for strong family history or
other genetic predisposition.

g. Woman and Minorities

EXCLUSION CRITERIA:

Pregnant or lactating subjects.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Authority:

United States: Federal Government

Study ID:

100042

NCT ID:

NCT01052740

Start Date:

December 2009

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • Invasive Carcinoma
  • In Situ Carcinoma
  • Fibrocystic Changes
  • Atypical Ductal Hyperplasia
  • Breast Cancer
  • Mammography
  • Screening
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Hyperplasia

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892