Tissue Validation of Mammographic Breast Arterial Calcification in Mastectomy Specimens (SIDEMARA)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40+
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

About this trial

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.

This 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.

As a secondary and exploratory objective, coronary artery calcification will be scored from staging computed tomography images already acquired for cancer staging.

No 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Aged 40 years or older

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

Full-field digital mammogram performed within 6 months before surgery and available for review

Disqualifiers

Neoadjuvant chemotherapy or neoadjuvant endocrine therapy

Previous surgery or radiotherapy to the ipsilateral breast

Previous radiotherapy to the thoracic region

Breast implant

Trial population

Consecutive women undergoing upfront mastectomy for breast cancer at a single tertiary training and research hospital in Istanbul, Turkey.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Women undergoing upfront mastectomy

Trial outcomes

Primary outcomes

1

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.

Time frame
From surgery to completion of histopathological assessment, up to 2 months per participant

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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