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China CellSearch Study

NCT01116869 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-11-15

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Johnson & Johnson Medical, China

    lead INDUSTRY

Principal Investigators

  • Zefei Jiang, Doctor · 307 Hosptial of PLA

  • Zhimin Shao, Doctor · Shanghai Cancer Hosptial

  • Tao Ouyang, Doctor · Beijing Cancer Hosptial

  • Erwei Song, Doctor · Zhongshan 2nd Hospital

  • Ning Liao, Doctor · The Second People's Hospital of GuangDong Province

  • Xiaojia Wang, Doctor · Zhejiang Cancer Hosptial

  • Zhongsheng Tong, Doctor · Tianjin Cancer Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-25
Primary Completion
2011-06-22
Completion
2014-01-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116869 on ClinicalTrials.gov