EUCTR2009-014823-22-IT进行中（未招募）不适用
Second biopsy of axillary sentinel node in the local recurrence of breast cancer after mastectomy and first negative sentinel node. Studio LiSeR - M - ND
AZIENDA USL DI FORLI`0 个研究点开始时间: 2010年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •clinical diagnosis and / or instrumental first episode of local recurrence of breast cancer parietal (B5, C4, C5, surgical biopsy), surgically removed with negative axillary objectivity and, in cases of doubt or with lymph nodes> 2cm, with ultrasound examination and possible agoaspirato negative;
- •staging tests negative (rx thorax and / or tac chest, eco liver and / or tac abdomen, bone scintigraphy) performed over the last 6 months;
- •previously undergone a mastectomy (at least 1 year) for breast carcinoma in situ or invasive histologically confirmed and resection margins free of neoplasia;
- •previously undergone a biopsy of the LS were negative for the primary tumor is permissible, and should be reported in the data collection, the presence of isolated tumor cells (diameter <200 microns);
- •whether or not previously submitted to adjuvant chemotherapy completed at least 1 month;
- •whether or not previously subjected to intra or postoperative radiotherapy;
- •being treated or not with Ormonoterapia or biological therapies;
- •age ≥ 18 years, female;
- •written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •axillary lymph nodes clinically and instrumentally or cyto-histologically positive;
- •presence of distant metastases from breast cancer;
- •concomitant or previous malignancies other than the subject of the Study, except for cancers for which the patient is disease-free for at least 5 years;
- •concomitant or previous malignancy in the contralateral breast;
- •non-epithelial breast malignancies (sarcoma, lymphoma etc).
- •psychiatric illness or other nature which preclude provide informed consent to treatment;
- •are pregnant resolved;
- •breastfeeding;
- •known contraindications to the technique of LS.
研究者
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