China CellSearch Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-25

Study Completion Date

2014-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients

NCT02111031

Metastatic Breast Cancer Breast Cancer

WITHDRAWN

Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients

NCT02904135

Circulating Tumor Cells (CTCs)

COMPLETED

Culture of Circulating Tumor Cells Isolated From Cancer Patients With Metastatic Disease

NCT02781025

Circulating Tumor Cells

COMPLETED

Circulating Tumor Cells (CTC) in Cancer

NCT04520672

Cancer

RECRUITING

Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer

NCT05208372

Stomach Neoplasms Metastasis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Breast Cancer Benign Breast Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Benign disease volunteers

100 Benign disease volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

No interventions assigned to this group

Healthy volunteers

100 Healthy volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes