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Spots Global Cancer Trial Database for Cosmetic and Functional Outcomes After Breast Conserving Surgery

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Trial Identification

Brief Title: Cosmetic and Functional Outcomes After Breast Conserving Surgery

Official Title: The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study

Study ID: NCT01496001

Conditions

Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

National Institute of Oncology, Budapest, , Hungary

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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