Clinical Application of CTDNA in Operable Breast Cancer Patients
2016年6月11日 更新者：Qiang SUN、Peking Union Medical College Hospital
Our study aims to evaluate the possibility of clinical application of CTDNA detection in samples or peripheral blood of breast cancer patients, so as to act as the new techniques or indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast cancer.
研究概览
地位
未知
条件
研究类型
观察性的
注册 (预期的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Beijing
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Beijing、Beijing、中国、100730
- 招聘中
- Peking Union Medical College Hospital
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接触：
- Li Peng, Doctor
- 电话号码：86-010-69152701
- 邮箱：pl226@sina.com
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接触：
- Qiang Sun, Doctor
- 电话号码：86-010-69152701
- 邮箱：sunqiangpumc@163.com
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首席研究员：
- Yidong Zhou, Doctor
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副研究员：
- Li Peng, Doctor
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
概率样本
研究人群
Operable breast cancer patients who need chemotherapy before or after surgery.
描述
Inclusion Criteria:
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Age of at least 18 and at most 70 years.
- Performance status (Karnofsky-Index) >80%.
- Chemotherapy is necessary before or after surgery.
- No clinical evidence of local recurrence or distant metastases.
- Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
- Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
- Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
- Patients must be available for and compliant to treatment and follow-up.
- Patients registered on this trial must be treated and followed up at the participating center.
Exclusion Criteria:
- Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- Local recurrence and/or metastasis of breast cancer.
- No need of chemotherapy.
Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
- Males.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Neoadjuvant chemotherapy
ctDNA of operable breast cancer patients with neoadjuvant chemotherapy before surgery in different periods: before neo-chemotherapy, during neo-chemotherapy, on surgery day, after surgery and follow-up time.
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The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
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Surgery
ctDNA of operable breast cancer patients with surgery followed by adjuvant chemotherapy in different periods: on surgery day, after surgery, before adjuvant chemotherapy, during adjuvant chemotherapy, and follow-up time.
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The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The number of ctDNA copies per milliliter in patients' peripheral blood
大体时间：2 years
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The number of ctDNA copies per milliliter in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods
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2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Qiang Sun, Doctor、Peking Union Medical College Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.
- Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4.
- Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.
- Garcia-Murillas I, Schiavon G, Weigelt B, Ng C, Hrebien S, Cutts RJ, Cheang M, Osin P, Nerurkar A, Kozarewa I, Garrido JA, Dowsett M, Reis-Filho JS, Smith IE, Turner NC. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021.
- Zill OA, Greene C, Sebisanovic D, Siew LM, Leng J, Vu M, Hendifar AE, Wang Z, Atreya CE, Kelley RK, Van Loon K, Ko AH, Tempero MA, Bivona TG, Munster PN, Talasaz A, Collisson EA. Cell-Free DNA Next-Generation Sequencing in Pancreatobiliary Carcinomas. Cancer Discov. 2015 Oct;5(10):1040-8. doi: 10.1158/2159-8290.CD-15-0274. Epub 2015 Jun 24.
- Zhou Y, Xu Y, Wang C, Gong Y, Zhang Y, Yao R, Li P, Zhu X, Bai J, Guan Y, Xia X, Yang L, Yi X, Sun Q. Serial circulating tumor DNA identification associated with the efficacy and prognosis of neoadjuvant chemotherapy in breast cancer. Breast Cancer Res Treat. 2021 Aug;188(3):661-673. doi: 10.1007/s10549-021-06247-y. Epub 2021 May 18.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年5月1日
初级完成 (预期的)
2018年4月1日
研究注册日期
首次提交
2016年5月24日
首先提交符合 QC 标准的
2016年6月7日
首次发布 (估计)
2016年6月13日
研究记录更新
最后更新发布 (估计)
2016年6月14日
上次提交的符合 QC 标准的更新
2016年6月11日
最后验证
2016年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.