NCT05406661尚未招募不适用
Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain
研究概览
简要总结
The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain.
The comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Age > 18 years
- •Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer
- •and adjuvant breast RT: total (WBI) or partial (PBI)
- •without adjuvant radiotherapy to the breast
- •Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma
排除标准
- •Age < 18 years
- •Stage 4 at diagnosis
- •Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment
- •History of other primary invasive malignant tumor (except non-melanoma skin carcinomas)
- •Patients already treated for another local recurrence of breast carcinoma
- •Absence of clinical follow-up and records in clinical process
结局指标
主要结局
Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain
时间窗: 2 years
Number of cases per year
Follow-up of recurrences up to 5 years after treatment of first recurrence
时间窗: 5 years
Number of cases per year
次要结局
- Determination of surgical morbidity of relapse treatment in follow up(From date of treatment until 30 days after treatment)
- Assessment of patient quality of life(First and second year after treatment)
- Identification of risk factors for local recurrence(On inclusion time (2 years))
- Identification of predictive and response factors(On inclusion time (2 years))
研究者
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