An observational study in Breast Cancer, BRCA1 Mutation and BRCA2 Mutation, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by Seoul National University Hospital · Observational
Study Purpose:
A multicenter prospective study to evaluate the outcome of second breast cancer surveillance with abbreviated breast MR (AB-MR) or ultrasound (US) in addition to annual mammography in women with BRCA1/2 mutation testing
Study Scheme:
For women with a BRCA1/2 mutation who are treated for breast cancer, screening of remaining breast tissue with annual mammography and breast MRI is recommended. For women who met BRCA testing criteria but show an uninformative negative result or a variant of unknown significance (VUS) result, there is no established recommendation for second breast cancer surveillance.
Abbreviated breast MRI (AB-MR) is a fast and low-cost examination that show equivalent diagnostic accuracy to that of the standardized dynamic protocol breast MRI. Breast ultrasound (US) can detect additional cancers that are occult on mammography and is indicated in high-risk patients who cannot tolerate MRI.
The purpose of this multicenter prospective study is to evaluate the outcome of second breast cancer surveillance with AB-MR or US in addition to annual mammography in women with BRCA1/2 mutation testing.
AB-MR, US, and digital mammography will be performed on the same day at baseline and then after 1 year and images will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists. The BI-RADS category 3 or higher is defined as test-positive. The reference standard will be a biopsy or at least 1 year of follow-up.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 1,564 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Breast cancer patients who met BRCA testing criteria and undergo post-operative surveillance for secondary breast cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sensitivity and Specificity (co-primary)
To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer
Time frame: 1 year
Cancer detection rate (CDR)
To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography
Time frame: 1 year
Positive predictive value (PPV)
To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography
Time frame: 1 year
Negative predictive value (NPV)
To compare the NPV (no. of detected cancers / no. of negative examinations) of AB-MR, US, and mammography
Time frame: 1 year
Histopathologic characteristics of secondary breast cancers
To describe the histologic type, tumor grade, and molecular tumor subtype of secondary breast cancers detected at AB-MR, US, and mammography
Time frame: 1 year
Started May 2018 (actual). Primary completion is estimated for Jun 2022, 49 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 49 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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