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
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
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.
Observational Model: Case Control, Time Perspective: Prospective
Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.
Zefei Jiang, Doctor
307 Hosptial of PLA
China: Food and Drug Administration