Prospective multicenter clinical study about Intraoperative Margin Assessment with Click-to-sense (CTS) method using live cells of breast tissues stained Phenyl Azide Probe in Breast-Conserving Surgery for primary breast cancer. (IntaCTS study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 主要终点
- diagnostic accuracy of the CTS method
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Each facility will target patients who meet all the criteria below for eligibility for breast-conserving surgery in primary breast cancer patients (Tis-T2N0-1M0, stages 0-IIB).
- •TNM classification: Tis-T2, N0-1, M0 (based on the 4.1 clinical staging).
- •Age at registration must be 20 years or older (minors are excluded).
- •Patients who have undergone preoperative systemic therapy for breast cancer by the time of registration are also eligible. Cases involving preoperative systemic therapy (such as neoadjuvant chemotherapy or hormone therapy) will be categorized as Group B.
- •Informed consent for trial participation has been obtained from the patient themselves, as the informed consent document.
排除标准
- •The following criteria will excluded patients eligible for targeting:
- •TNM classification: Breast cancer with a tumor diameter exceeding 5 cm (T3 or higher), or breast cancer with metastasis to other organs M0 (as per the 4.1 clinical staging).
- •Age at registration is below 20 years.
- •Breast cancer patients for whom consent for trial participation has not been obtained from the patient themselves as outlined in the explanatory document.
- •Breast cancer patients deemed unsuitable by their attending physician.
结局指标
主要结局
diagnostic accuracy of the CTS method
The diagnostic accuracy of the CTS method against postoperative histopathological tissue diagnosis (based on permanent specimen sections), including measures of positive concordance rate, negative concordance rate, and overall concordance rate.
superiority of the CTS method's diagnostic accuracy over historical controls
The superiority of the CTS method's diagnostic accuracy over historical controls for intraoperative rapid pathological diagnosis using frozen sections (with approximately typical diagnostic accuracy rates of 80.0% for positive concordance, 95.0% for negative concordance, and 90.0% for overall concordance).
diagnostic accuracy for margin stump tissue
Subgroup analyses to assess the diagnostic accuracy (including positive concordance rate, negative concordance rate, and overall concordance rate) specifically for margin stump tissue in the control group.
diagnostic accuracy for cases undergoing preoperative medical therapy
Subgroup analyses to assess the diagnostic accuracy (including positive concordance rate, negative concordance rate, and overall concordance rate) specifically for cases undergoing preoperative medical therapy.
次要结局
- Diagnostic accuracy of intraoperative pathological tissue diagnosis
- Intraoperative additional excision of breast tissue
- Necessity for postoperative additional treatment