The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Primary outcome is the determination of the critical tumor / breast volume ratio in each quadrant, above of which number breast conserving surgery could not offer adequate cosmetic and functional results.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •early breast cancer
- •unilateral tumor
- •tumor size is less than 3 cm
排除标准
- •age over 70
- •malignant invasive tumor in the past
- •pregnancy
- •previous surgical treatment of the breast or axilla
- •central breast tumor sizing <3 cm
- •a need for mastectomy
- •tumor size >3 cm measured by mammography or physical examination
- •surgical excisions resulting in positive margins
- •surgical or radiotherapeutic complication
研究组 & 干预措施
Cohort
干预措施: Lumpectomy, axillary block dissection, breast conserving surgery (Procedure)
Cohort
干预措施: Radiotherapy (Other)
结局指标
主要结局
Primary outcome is the determination of the critical tumor / breast volume ratio in each quadrant, above of which number breast conserving surgery could not offer adequate cosmetic and functional results.
时间窗: 8 months
Data of eligible patients are recorded by the study physicians on a locally developed questionnaire. Digital photos are taken of each patient producing a frontal and two side views. Images are processed by the BCCT.core software (Breast Cancer Conservation Treatment. cosmetic results). Magnetic resonance imaging is implemented and used to calculate breast volume with the help of Amira 5.1 software (Visage Imaging GmbH)trial version. Excised tumor is measured by a validated analytical scale.
次要结局
- Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life.(During 8 postoperative months)
- Assessing the relationship between cosmetic+functional results and quality of life.(8 months for each patient)
- Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS).(8 months for each patient)
- Assessing the clinical applicability of the BCCT.core software.(8 months)
- Assessing the effect of surgical intervention on cosmetic+functional results and quality of life.(During 8 postoperative months)
- Assessing the clinical applicability of the European Organisation of Research and Treatment of Cancer, Quality of Life Questionnaire C30-BR23 (EORTC QoL C30-BR23) validated questionnaire.(8 months)
研究者
Dr. Zoltan Matrai
Principal Investigator
National Institute of Oncology, Hungary