X-Ray Mammography Standard of Care Protocol

NCT01052740 | Completed

• 2 other identifiers: 10004210-CC-0042
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Invasive Carcinoma; In Situ Carcinoma; Fibrocystic Changes; Atypical Ductal Hyperplasia

Keywords

Breast Cancer; Mammography; Screening

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Pregnant or lactating subjects.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1016/j.jacr.2004.12.005.

  PMID: 17411883 BACKGROUND

• 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. doi: 10.1148/radiol.2411051375.

  PMID: 16990672 BACKGROUND

• Belkacemi Y, Bousquet G, Marsiglia H, Ray-Coquard I, Magne 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. doi: 10.1016/j.ijrobp.2007.06.059. Epub 2007 Oct 10.

  PMID: 17931796 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma in Situ; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Breast Carcinoma In Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 16, 2010
• First Posted: January 20, 2010
• Study Start: December 30, 2009
• Study Completion: September 20, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-09-20

Locations

US (1)