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
18 Years
70 Years
Female
Metastatic Breast Cancer, Benign Breast Disease
Trial Information
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
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.
Inclusion Criteria
Inclusion Criteria
- Female
- over 18 and less than 70 years of age
- Subject having agreed to participate in the study and follow the study procedures by
providing written informed consent prior entering the study.
- For MBC Subject Set only Confirmed metastatic breast cancer patient with at least one
measurable solid tumor according to the RECIST guideline Starting a new line of
systemic therapy which is recommended in the Chinese edition of NCCN Clinical
Practice Guidelines in Oncology Breast Cancer Guideline 2009 line of chemotherapy
should be over 3 ECOG performance grade of 0 to 2 Life expectancy over 3 months
- For Healthy Subject Set only Medical examinations detect no breast benign and
malignant tumors
- For Benign Breast Disease Subject Set only Pathology diagnosed breast benign tumor
disease
Exclusion Criteria
- Self reported pregnancy
- For MBC Subject Set only Prior history of other malignancy Patients who have surgery
to remove any metastatic lesions or receive radiation therapy during her
participation in the study
- For Healthy Subject Set only Prior history of breast benign tumor disease or any
malignancy Any conditions inappropriate for blood drawing
- For Benign Breast Disease Subject Set only Prior history of any malignancy Any
conditions inappropriate for blood drawing
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.
Outcome Time Frame:
12 months
Safety Issue:
Yes
Principal Investigator
Zefei Jiang, Doctor
Investigator Role:
Study Chair
Investigator Affiliation:
307 Hosptial of PLA
Authority:
China: Food and Drug Administration
Study ID:
200901
NCT ID:
NCT01116869
Start Date:
March 2010
Completion Date:
December 2013
Related Keywords:
- Metastatic Breast Cancer
- Benign Breast Disease
- MBC
- Healthy
- Benign disease
- Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline
- Medical examinations detect no breast benign and malignant tumors
- Benign Breast Disease
- Pathology diagnosed breast benign tumor disease
- Breast Neoplasms
- Breast Diseases
- Fibrocystic Breast Disease
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