X-Ray Mammography Standard of Care Protocol

Tracking Information
First Submitted Date	January 16, 2010
First Posted Date	January 20, 2010
Last Update Posted Date	July 2, 2017
Study Start Date	December 30, 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01052740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	X-Ray Mammography Standard of Care Protocol
Official Title	X-Ray Mammography Standard of Care Protocol
Brief 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.
Study Type	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Breast Cancer; Invasive Carcinoma; In Situ Carcinoma; Fibrocystic Changes; Atypical Ductal Hyperplasia
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Destouet JM, Bassett LW, Yaffe MJ, Butler PF, Wilcox PA. The ACR's Mammography Accreditation Program: ten years of experience since MQSA. J Am Coll Radiol. 2005 Jul;2(7):585-94.; Geller BM, Ichikawa LE, Buist DS, Sickles EA, Carney PA, Yankaskas BC, Dignan M, Kerlikowske K, Yabroff KR, Barlow W, Rosenberg RD; Breast Cancer Surveillance Consortium. Improving the concordance of mammography assessment and management recommendations. Radiology. 2006 Oct;241(1):67-75.; Belkacémi Y, Bousquet G, Marsiglia H, Ray-Coquard I, Magné N, Malard Y, Lacroix M, Gutierrez C, Senkus E, Christie D, Drumea K, Lagneau E, Kadish SP, Scandolaro L, Azria D, Ozsahin M. Phyllodes tumor of the breast. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):492-500. Epub 2007 Oct 10.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: September 23, 2011)	108
Original Estimated Enrollment; (submitted: January 16, 2010)	4000
Study Completion Date	September 20, 2011
Primary Completion Date	Not Provided
Eligibility 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: All women who fall under the ACS mammography guidelines; Women younger than 40 years but with more than 20% lifetime risk for developing breast cancer: 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. 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. 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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 100 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01052740
Other Study ID Numbers	100042; 10-CC-0042
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	National Institutes of Health Clinical Center (CC)
Collaborators	Not Provided
Investigators	Not Provided
PRS Account	National Institutes of Health Clinical Center (CC)
Verification Date	September 20, 2011