NCT03973034Unknown不适用
Clinical Application of ctDNA in Early Screening of Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- ctDNA test model for early screening of breast cancer
研究概览
简要总结
The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening 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.
- •Normal people who works as the volunteers.
- •Benign breast disease patients should be diagnosed with confirmed pathology after surgery.
- •Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.
- •Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
排除标准
- •Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- •Local recurrence and/or metastasis of breast cancer.
- •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).
- •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
ctDNA test model for early screening of breast cancer
时间窗: 2 years
次要结局
未报告次要终点
研究者
相似试验
尚未招募
不适用
The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung CancerStereotactic Body Radiation TherapyNCT05411809Peking University Third Hospital180
招募中
不适用
Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic CancerResectable Pancreatic CancerNCT05788744Copenhagen University Hospital at Herlev1,000
招募中
不适用
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid TumorsHealthy VolunteerHead and Neck CancerGenitourinary CancerGastrointestinal CancerSolid Tumor CancerBreast CancerProstate CancerLung CancerMelanomaEsophageal CancerColon CancerSarcomaSkin CancerNCT04354064Washington University School of Medicine100
招募中
不适用
Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical CancerLocally Advanced Cervical CancerNCT05602831Fudan University108
招募中
不适用
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic CancersHepatobiliary CancerAmpullary CancerPancreatic CarcinomaCholangiocarcinomaPancreatic CancerHepatocellular CarcinomaNCT05497531University of California, Irvine15