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

• Conditions: Cancer

• Registration Number: NCT01022723
• Lead Sponsor: National Cancer Centre, Singapore

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 817

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types	3 years

Secondary Outcome Measures

Name	Time	Method
Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics	6 years
Characteristics and viability of the CTC with this capture method	3 years
Clinical application of this capture method with the study of CTC titre correlation to treatment outcome	6 years

Trial Locations

Locations (1)

National Cancer Centre; 🇸🇬 Singapore, Singapore