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Brief Title: China CellSearch Study
Official Title: A Multi-Center, Prospective Study to Evaluate the Ability of CTC Enumeration Using the CellSearch® Circulating Tumor Cell Kit to Predict Prognosis and to Assess the Agreement Between CTC and Imaging Determined Response in MBC Patients 一项评价CellSearch® 循环肿瘤细胞检测试剂盒对复发转移性乳腺癌患者进行循环肿瘤细胞检测 以预测病人预后的能力及循环肿瘤细胞检测和影像学疗效判断之间一致性的多中心、前瞻性的研究
Study ID: NCT01116869
Brief Summary: The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China. The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. This test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
Detailed Description: A longitudinal, multi-center, prospective study will be conducted in MBC patients to evaluate the ability of CTC to predict the patients' prognosis. A separate population of healthy and benign disease subjects will serve as controls to compare the CTC incidence in this control group versus the MBC group at baseline. Correlation between CTC and radiographic response to the systemic therapies in the MBC study group will also be assessed. 300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival. 200 healthy and benign disease volunteers, each of whom will donate blood 1 time for CTC analysis, will be enrolled as controls.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
307 Hosptial of PLA, Beijing, , China
Name: Zefei Jiang, Doctor
Affiliation: 307 Hosptial of PLA
Role: STUDY_CHAIR
Name: Zhimin Shao, Doctor
Affiliation: Shanghai Cancer Hosptial
Role: PRINCIPAL_INVESTIGATOR
Name: Tao Ouyang, Doctor
Affiliation: Beijing Cancer Hosptial
Role: PRINCIPAL_INVESTIGATOR
Name: Erwei Song, Doctor
Affiliation: Zhongshan 2nd Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ning Liao, Doctor
Affiliation: The Second People's Hospital of GuangDong Province
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaojia Wang, Doctor
Affiliation: Zhejiang Cancer Hosptial
Role: PRINCIPAL_INVESTIGATOR
Name: Zhongsheng Tong, Doctor
Affiliation: Tianjin Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR