X-Ray Mammography Standard of Care Protocol
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ClinicalTrials.gov Identifier: NCT01052740 |
Recruitment Status
:
Completed
First Posted
: January 20, 2010
Last Update Posted
: July 2, 2017
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Tracking Information | |||
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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:
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:
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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. |
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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 |
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Intervention | Not Provided | ||
Study Groups/Cohorts | Not Provided | ||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
108 | ||
Original Estimated Enrollment |
4000 | ||
Study Completion Date | September 20, 2011 | ||
Primary Completion Date | Not Provided | ||
Eligibility 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:
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Sex/Gender |
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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 |
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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 |