Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT01116869
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2010-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
China CellSearch Study
Sponsor:
Johnson & Johnson Medical, China
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: