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临床试验 NCT04052893 针对乳腺肿瘤目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
改良根治性乳房切除术与扩大McKissock术治疗乳腺EIC后的无病生存率与生活质量比较 200
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临床试验NCT04052893是一项针对乳腺肿瘤的干预性研究试验，目前试验状态为招募中。试验始于2019年10月1日，计划招募200名患者。该研究由Shengjing Hospital主导，预计于2026年9月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2022年2月8日。
简要概括
Extensive intraductal carcinoma of the breast refers to a type of breast cancer in which ≥ 25% of ductal carcinoma in situ is present in invasive tumors and there is a scattered distribution of ductal carcinoma in situ (DCIS) in or around the invasive carcinoma. Compared with DCIS negative for extensive intraductal component, DCIS positive for extensive intraductal component is not sensitive to radiotherapy. Mckissoc...显示更多
详细描述
Extensive intraductal carcinoma of the breast refers to a type of breast cancer in which ≥ 25% of ductal carcinoma in situ is present in invasive tumors and there is a scattered distribution of ductal carcinoma in situ (DCIS) in or around the invasive carcinoma. Studies have shown that patients with DCIS positive for extensive intraductal component have more residual tumors than patients with DCIS negative for extens...显示更多
官方标题
Postoperative Disease-free Survival and Quality of Life After Modified Radical Mastectomy Versus Expanded Mckissock Surgery for Extensive Intraductal Carcinoma of the Breast: a Prospective Cohort Study Protocol
疾病
乳腺肿瘤其他研究标识符
- Shengjing-LJY02
NCT编号
实际开始日期
2019-10-01
最近更新发布
2022-02-08
预计完成日期
2026-09-01
计划入组人数
200
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Surgery
Plastic
Plastic
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Study group 100 patients will be assigned into a study group. | Expanded Mckissock surgery Expanded Mckissock surgery: (1) According to patient's preoperative imaging results and subjective expectations of their own breast morphology, the incision design and breast surface marking will be performed under the standing position. (2) After general anesthesia, the upper limbs will be abducted, and the upper body will be tilted by 15°-20° to dermatize the labeled skin around and below the areola. (3) The medial...显示更多 |
阳性对照Control group 100 patients will be assigned into a control group. | Modified radical mastectomy The patients will be placed in the supine position. After intravenous anesthesia, the tumor boundary will be marked and the breast will be removed. The vertical subcutaneous pedicle flaps will be W-folded, and the flaps on both sides will be pulled to the vertical pedicle to reshape the breast. During this process, the breast and armpit drainage tubes will be indwelled. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Disease-free survival. | Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death. | 5 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23) scale | The QLQ-BR23 scale will evaluate the quality of life. The QLQ-BR23 scale consists of 23 items with a full score of 92. Higher score indicates poor quality of life. | 5 years |
Breast symmetry | The symmetry of reconstructed breast will be evaluated using Harris score. The Harris score was described by Harris et al. (Int J Radiat Oncol Biol Phys 1979; 5: 257- 261.) It will be divided into four levels: excellent, good, fair, and poor. | 5 years |
Medical cost | Including medical insurance and commercial insurance reimbursement. | During hospitalization, an average of 2 weeks |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
45 Years
适龄性别
女性
- Patients with extensive intraductal carcinoma confirmed by hollow needle biopsy;
- the lesion not involving the nipple as confirmed by enhanced MR imaging of the breast;
- Bra cup size: B or higher;
- postmenopausal patients;
- provision of written informed consent.
- The cutting edge of nipple-areola complex tested positive for extensive intraductal carcinoma twice;
- preoperative nipple hemorrhage;
- bilateral breast cancer;
- inflammatory breast cancer;
- distant metastasis;
- other cancers or those who receive chest radiotherapy.
Shengjing Hospital研究责任方
Jianyi Li, 主要研究者, Principal Investigator, Shengjing Hospital
研究中心联系人
联系人: Jianyi Li, +8618940257177, [email protected]
3 位于 1 个国家/地区的研究中心
Liaoning
General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group, Benxi, Liaoning, 117000, China
Qiang Sun, MS, 联系人, 13390358188, [email protected]
Qiang Sun, MS, 主要研究者
招募中
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shengyang, Liaoning, 110042, China
Jianyi Li, Dr., 联系人, 13390127607, [email protected]
招募中
Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China
Jianyi Li, 联系人, +8618940257177, [email protected]
招募中