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NCT Number: NCT01116869

China CellSearch Study

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.

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Key information

Conditions

Metastatic Breast Cancer Benign Breast Disease Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Respiratory Tract Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

307 Hosptial of PLA

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.

    Time frame: 12 months

Secondary outcomes

  1. Ability of CTC levels to predict overall survival (OS) in MBC patients.

    Time frame: 3 years

  2. 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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Medical, China

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
May 5, 2010
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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