Breast CancerNCT00255060
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
An observational study of Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jun 2007
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with high risk of breast cancer
Inclusion Criteria:Subjects must be female, between the ages of 25 and 65, or ten years younger than the youngest breast cancer diagnosed in the family, or have no mutation identified but have a greater than 10% risk of developing breast cancer in ten years (based on the Claus Model).
May have had previous breast or ovarian cancer, but must be at least one year out from treatment of a Stage 1 or early 2 cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.
Read the detailed description
General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.
The following are our specific goals in this endeavor;
- To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
- To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
- To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a >10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startNov 2001
- Primary completionJul 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), United States Department of Defense
- Investigators
- James M Ford, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255060
- Sponsor's protocol ID
- BRSNSTU0002
- Other IDs
- 77716, BRSNSTU0002, NCT00255060
- Status last verified
- Jul 2010
- First submitted
- 15 Nov 2005
- Last updated
- 20 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
- ClinicalTrials.gov ID
- NCT00255060
- Acronym / sponsor ID
- BRSNSTU0002
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), United States Department of Defense
- Study start
- Nov 2001
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 17 Nov 2005 (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.
To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.
Detailed description
General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.
The following are our specific goals in this endeavor;
- To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
- To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
- To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a >10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with high risk of breast cancer
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 20 Jul 2010.
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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.
James M Ford principal investigator
Stanford University
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, run by Stanford University 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?
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 20 Jul 2010. 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?
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 20 Jul 2010.