Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells (CTC)

National Cancer Centre, Singapore

Status: Unknown

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01022723

CTC_ver2_081109

Details and patient eligibility

About

To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.

Full description

• Validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types
• Characterize and identify these circulating tumor cells and demostrate cell viability with this capture method
• Apply this technology in clinically relevant settings and correlate to response to treatment and disease progression
• Elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics

Enrollment: 817 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with newly diagnosed metastatic disease planned for palliative chemotherapy
• Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer
• Informed consent given for the purposes of blood sampling for this study
• Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual

Exclusion criteria

• N/A

Trial design

817 participants in 6 patient groups

Lung Cancer patients

Description:

Lung Cancer (particular focus on non smokers with adenocarcinoma)

Patients with Nasopharyneal carcinoma

Description:

Patients with Nasopharyneal carcinoma

Breast Cancer patients

Description:

Breast cancer patients

Prostate Cancer patients

Description:

Prostate cancer patients

Colorectal Cancer patients

Description:

Colorectal cancer patients

Gastric Cancer patients

Description:

Gastric cancer patients