Breast Cancer Clinical Trial
Official title:
The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
The initial aesthetic and functional conditions are recorded with the help of the Breast
Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the
Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer
software, allowing for comparison. Determination of the initial quality of life is measured
with the European Organisation of Research and Treatment of Cancer - Quality of Life
Questionnaire number C30-BR23 (EORTC QoL C30-BR23).
Patients then undergo surgical treatment according to institutional protocols. Following
conventional marking of the orientation of the specimen, it is measured by an analytical
scale.
Histological examination of the specimen will record the largest diameters, and parameters
of the lymph nodes, according to the institutional protocol.
On the 4th week following surgery, assuming that wound healing is completed, patients' data
are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are
gained after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic
resonance imaging is performed to assess the volume of the contralateral breast.
Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each
quadrant, threshold value in the quadrants, above of which it is not advisable to perform
conventional breast conserving surgery due to poor outcomes.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label
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