NCT02797652Unknown不适用
Clinical Application of CTDNA in Operable Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The number of ctDNA copies per milliliter in patients' peripheral blood
研究概览
简要总结
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The number of ctDNA copies per milliliter in patients' peripheral blood
时间窗: 2 years
The number of ctDNA copies per milliliter in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods
次要结局
未报告次要终点
研究者
Qiang SUN
Professor
Peking Union Medical College Hospital
研究点 (1)
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