[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659539":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":13,"overallOfficials":13,"centralContacts":23,"locations":13,"responsibleParty":29,"collaborators":13,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":13,"enrollmentInfo":43,"targetDuration":13,"studyType":46,"phases":13,"briefSummary":47,"conditions":48,"keywords":53,"overallStatus":59,"whyStopped":13,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":13},{"fullName":5,"class":6},"Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Sensitivity of mammography for histopathologically confirmed medial arterial calcification","Proportion of cases with histopathologically confirmed medial calcification of breast arteries in which breast arterial calcification is also reported on the preoperative mammogram. Histopathology serves as the reference standard. Reported with a 95 percent confidence interval calculated by the Wilson method. The primary inference is drawn from the upper limit of this interval.","From surgery to completion of histopathological assessment, up to 2 months per participant",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","This is a single-centre, prospective, cross-sectional diagnostic accuracy study. There is no randomisation, no control group and no intervention.\n\nRationale. Artificial-intelligence-based quantification of BAC in a cohort of 123,762 women has shown a dose-response relationship with major adverse cardiovascular events and incremental prognostic value over conventional risk scores. Systematic reviews support this association. Two questions remain unresolved. First, BAC is thought to be located in the tunica media rather than the tunica intima, making it medial arterial calcification rather than atherosclerosis, but direct histopathological verification in breast tissue is very limited. Second, and more critically, the field has no external reference standard: reported sensitivity values measure agreement with a human reader, not with tissue.\n\nSpecimen Handling The operation is not modified for the study. The specimen is oriented in theatre with two sutures (single suture superior, double suture lateral). In addition to diagnostic sampling, six research blocks are taken from macroscopically tumour-free areas: two from the upper outer quadrant, one from the upper inner quadrant, one from the lower quadrants, one from deep tissue adjacent to the prepectoral fascia and one from the central or retroareolar region. If there is any doubt about the adequacy of tissue for diagnosis, no additional block is taken; correct diagnosis always takes precedence.\n\nHistopathological Assessment A stepwise staining algorithm is used: routine haematoxylin and eosin on all six blocks; von Kossa on blocks containing arteries of assessable calibre; elastic van Gieson on cases with calcification, to determine the layer involved. Presence, location (medial or intimal), circumferential extent and a 0-3 ordinal severity score are recorded, together with morphometric measurements made in free software. Intimal lesions are graded 0-4 using predefined morphological criteria, with grade 2 or above classified as atherosclerotic change. No additional immunohistochemistry is performed.\n\nMammographic Assessment The existing preoperative digital mammogram is read primarily in the mediolateral oblique projection. Presence of BAC, a 0-3 ordinal severity score and an estimated calcification area in square millimetres are recorded.\n\nCoronary artery calcification.Ordinal scoring is performed on staging PET-CT or thoracic CT images already acquired. The reader is a radiologist or nuclear medicine physician who is not among the mammography readers of this study. Cases without thoracic imaging, and those with previous coronary revascularisation, are excluded from this sub-analysis but remain in the primary analysis.\n\nBlinding The pathologist is blind to mammographic and coronary findings. The mammography reader is blind to histopathology and coronary findings. The coronary calcification reader is blind to histopathology, mammography and the patient's clinical cardiovascular history. Twenty per cent of cases are re-read by independent second readers to measure inter-observer agreement.\n\nStatistics. With histopathology as the reference standard, sensitivity, specificity and predictive values of mammography are estimated with 95 per cent confidence intervals by the Wilson method. Because this is a preliminary study, the primary inference is drawn from the upper limit of the confidence interval rather than from the point estimate. Reporting follows the STARD guideline.","Consecutive women undergoing upfront mastectomy for breast cancer at a single tertiary training and research hospital in Istanbul, Turkey.",[20],{"label":21,"type":13,"description":22,"interventionNames":13},"Women undergoing upfront mastectomy","Women aged 40 years and older undergoing mastectomy without neoadjuvant therapy for invasive breast carcinoma or ductal carcinoma in situ, with a preoperative digital mammogram available for review.",[24],{"name":25,"role":26,"phone":27,"phoneExt":13,"email":28},"Adnan Gündoğdu, Medical Doctor","CONTACT","+90 5367173909","adnangundogdu89@gmail.com",{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Adnan Gundogdu","MD","100659539","tissue-validation-of-mammographic-breast-arterial-calcification-in-mastectomy-specimens-sidemara-100659539",false,"NCT07865884","Tissue Validation of Mammographic Breast Arterial Calcification in Mastectomy Specimens (SIDEMARA)","Does Breast Artery Histopathology Reflect Systemic Atherosclerosis in Patients Undergoing Upfront Mastectomy? Relationship With Mammographic and Coronary Artery Calcification: A Prospective Preliminary Study","SIDEMARA","Inclusion Criteria:\n\n* Female\n* Aged 40 years or older\n* Scheduled for mastectomy for invasive breast carcinoma or ductal carcinoma in situ. All mastectomy types are eligible: simple, modified radical, skin-sparing, nipple-sparing and subcutaneous\n* Full-field digital mammogram performed within 6 months before surgery and available for review\n* Written informed consent\n\nExclusion Criteria:\n\n* Neoadjuvant chemotherapy or neoadjuvant endocrine therapy\n* Previous surgery or radiotherapy to the ipsilateral breast\n* Previous radiotherapy to the thoracic region\n* Breast implant\n* Inflammatory breast carcinoma\n* Male breast cancer\n* Chronic haemodialysis treatment\n* Known hereditary disorder of vascular calcification\n* Only analogue film mammography available\n* Mammographic images not assessable","FEMALE","40 Years",{"count":44,"type":45},100,"ESTIMATED","OBSERVATIONAL","Breast arterial calcification (BAC) is a common incidental finding on screening mammograms and has been associated with cardiovascular disease in women. However, every study in this field has been imaging-based. The accuracy of mammography for detecting breast arterial calcification has only ever been measured against another radiologist reading the same mammogram, never against the tissue itself. As a result, it is not known how much calcification mammography misses, nor whether what it shows represents medial (Monckeberg-type) calcification or true atherosclerosis.\n\nThis prospective observational study compares mammographic BAC with the histopathology of breast arteries obtained from mastectomy specimens. Women aged 40 years and older undergoing upfront mastectomy, without neoadjuvant therapy, for invasive breast cancer or ductal carcinoma in situ will be enrolled consecutively. Additional tissue blocks will be taken from tumour-free areas of the specimen and examined with von Kossa and elastic van Gieson stains to determine whether arterial calcification is present and whether it lies in the media or the intima. These findings will be compared with the preoperative mammogram, which is read independently and blind to the pathology result.\n\nAs a secondary and exploratory objective, coronary artery calcification will be scored from staging computed tomography images already acquired for cancer staging.\n\nNo additional tests, imaging, radiation exposure or blood sampling will be performed for the purposes of this study, and the surgical procedure will not be altered in any way.",[49,50,51,52],"Breast Cancer","Vascular Calcification","Coronary Artery Calcification","Atherosclerosis Cardiovascular Disease",[54,55,56,57,58],"breast cancer","vascular calcification","breast arterial calcification","coronary artery calcification","atherosclerosis","NOT_YET_RECRUITING","2026-10-03",{"date":62,"type":63},"2026-10-08","ACTUAL",{"date":65,"type":45},"2026-10-15",{"date":67,"type":45},"2027-12-30",{"name":5,"class":6}]