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China CellSearch Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Johnson & Johnson Medical, China.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier:
NCT01116869
First received: May 4, 2010
Last updated: May 29, 2013
Last verified: September 2011
  Purpose

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.


Condition
Metastatic Breast Cancer
Benign Breast Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Medical, China:

Primary Outcome Measures:
  • Ability of CTC levels to predict progression-free survival (PFS) in MBC patients. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ability of CTC levels to predict overall survival (OS) in MBC patients. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Agreement between CTC counts (3-4 weeks and 6-8 weeks) after the initiation of a new line of systemic therapy and the patient's response as determined by imaging evaluation (6-8 weeks after the initiation of therapy) in MBC patients. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
MBC patients
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.
Benign disease volunteers
100 Benign disease volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.
Healthy volunteers
100 Healthy volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The hazard ratio of disease progression in patients with unfavorable versus favorable CTC counts at baseline, 3-4 weeks and 6-8 weeks after the initiation of therapy will be estimated using Cox regression.

Kaplan-Meier plots for PFS will be constructed using the favorable and unfavorable CTC patient groups. The log-rank test will be used to determine if the curves for the two CTC groups are statistically significantly different.

The hazard ratio of death in patients with unfavorable versus favorable CTC counts at each blood draw time point will be estimated using Cox regression. Kaplan-Meier plots for OS will be constructed using the favorable and unfavorable CTC patient groups.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116869

Locations
China
307 Hosptial of PLA
Beijing, China
Sponsors and Collaborators
Johnson & Johnson Medical, China
Investigators
Study Chair: Zefei Jiang, Doctor 307 Hosptial of PLA
Principal Investigator: Zhimin Shao, Doctor Shanghai Cancer Hosptial
Principal Investigator: Tao Ouyang, Doctor Beijing Cancer Hosptial
Principal Investigator: Erwei Song, Doctor Zhongshan 2nd Hospital
Principal Investigator: Ning Liao, Doctor Guangdong People's Hospital
Principal Investigator: Xiaojia Wang, Doctor Zhejiang Cancer Hosptial
Principal Investigator: Zhongsheng Tong, Doctor Tianjin Cancer Hospital
  More Information

No publications provided

Responsible Party: Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier: NCT01116869     History of Changes
Other Study ID Numbers: 200901
Study First Received: May 4, 2010
Last Updated: May 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Johnson & Johnson Medical, China:
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

Additional relevant MeSH terms:
Breast Diseases
Breast Neoplasms
Fibrocystic Breast Disease
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014