Breast CancerNCT01052740
X-Ray Mammography Standard of Care Protocol
An observational study of Breast Cancer and Invasive Carcinoma, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer, Invasive Carcinoma, In Situ Carcinoma
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2009to 20 Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 17Show fewer
- First degree relative diagnosed with breast, ovarian, fallopian tube, or primary peritoneal cancer.
- Individual from families known to have BRCA 1 or 2 gene mutation.
- Close male blood relative with breast cancer.
- Genetic predisposition;
- Carry or have first-degree relative who carries a genetic mutation in the BRCA 1 or 2 genes.
- 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).
- A personal history of Lobular carcinoma in situ (LCIS) and/or atypical ductal hyperplasia (ADH)
- Prior personal history of breast cancer or ovarian cancer.
- Starting at the age of 25 year for Hereditary breast and ovarian cancer patients.
- 5-10 years prior to youngest breast cancer case for strong family history or other genetic predisposition.
- Woman and Minorities
Who cannot join
- Pregnant or lactating subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer, Invasive Carcinoma, In Situ Carcinoma, Fibrocystic Changes, Atypical Ductal Hyperplasia
- Keywords
- Breast Cancer, Mammography, Screening
- Medical subject headings
- Breast Neoplasms, Carcinoma in Situ, Carcinoma, Intraductal, Noninfiltrating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study start30 Dec 2009
- Study completion20 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052740
- Sponsor's protocol ID
- 100042
- Other IDs
- 10-CC-0042
- Status last verified
- 20 Sep 2011
- First submitted
- 16 Jan 2010
- Last updated
- 2 Jul 2017
- Results posted
- No
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. doi: 10.1016/j.jacr.2004.12.005.
PubMed 17411883Geller 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.
PubMed 16990672Belkacemi 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.
PubMed 17931796
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- X-Ray Mammography Standard of Care Protocol
- ClinicalTrials.gov ID
- NCT01052740
- Acronym / sponsor ID
- 100042
- Conditions
- Breast Cancer, Invasive Carcinoma, In Situ Carcinoma, Fibrocystic Changes, Atypical Ductal Hyperplasia
- Keywords
- Breast Cancer, Mammography, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 30 Dec 2009
- Study completion
- 20 Sep 2011
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (1 listed)
- Pregnant or lactating subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 17411883Destouet 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.
- Background: PubMed 16990672Geller 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.
- Background: PubMed 17931796Belkacemi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Invasive Carcinoma, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01052740, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.