Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells - Full Text View

Sponsor:	National Cancer Centre, Singapore
Collaborators:	National Medical Research Council (NMRC), Singapore National University, Singapore
Information provided by:	National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:	NCT01022723

Purpose

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

Condition	Intervention
Cancer	Procedure: Blood taking

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Centre, Singapore:

Biospecimen Retention: Samples With DNA

Circulating Tumor Cells

Estimated Enrollment:	366
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Lung Cancer patients Lung Cancer (particular focus on non smokers with adenocarcinoma)	Procedure: Blood taking venous blood sampling of 10ml into EDTA tubes for circulating tumor cells capture at the following time intervals: Pre-treatment, after two cycles of therapy, at best response and at progression
Patients with Nasopharyneal carcinoma Patients with Nasopharyneal carcinoma	Procedure: Blood taking venous blood sampling of 10ml into EDTA tubes for circulating tumor cells capture at the following time intervals: Pre-treatment, after two cycles of therapy, at best response and at progression
Breast Cancer patients Breast cancer patients	Procedure: Blood taking venous blood sampling of 10ml into EDTA tubes for circulating tumor cells capture at the following time intervals: Pre-treatment, after two cycles of therapy, at best response and at progression
Prostate Cancer patients Prostate cancer patients	Procedure: Blood taking venous blood sampling of 10ml into EDTA tubes for circulating tumor cells capture at the following time intervals: Pre-treatment, after two cycles of therapy, at best response and at progression
Colorectal Cancer patients Colorectal cancer patients	Procedure: Blood taking venous blood sampling of 10ml into EDTA tubes for circulating tumor cells capture at the following time intervals: Pre-treatment, after two cycles of therapy, at best response and at progression
Gastric Cancer patients Gastric cancer patients	Procedure: Blood taking venous blood sampling of 10ml into EDTA tubes for circulating tumor cells capture at the following time intervals: Pre-treatment, after two cycles of therapy, at best response and at 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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with the following cancers:

Lung Cancer Nasopharyneal carcinoma Breast cancer Prostate cancer Colorectal cancer Gastric cancer

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022723

Contacts

Contact: Samantha Lee P Kuan, Primary

+6564368539

Lee.Phei.Kuan@nccs.com.sg

Locations

Singapore
National Cancer Centre	Recruiting
Singapore, Singapore
Principal Investigator: Lim W Teck, Medical

Sponsors and Collaborators

National Cancer Centre, Singapore

National Medical Research Council (NMRC), Singapore

National University, Singapore

Investigators

Principal Investigator:

Lim Wan Teck, Dr

National Cancer Centre, Singapore

More Information

No publications provided

Responsible Party:	Dr Darren Lim Wan Teck, National Cancer Centre
ClinicalTrials.gov Identifier:	NCT01022723 History of Changes
Other Study ID Numbers:	CTC_ver2_081109
Study First Received:	November 30, 2009
Last Updated:	November 30, 2009
Health Authority:	Singapore:SingHealth Centralised Review Board

Keywords provided by National Cancer Centre, Singapore:

Circulating tumor cells
metastasis
cancer

cell isolation
mircofludics
cell detection

Additional relevant MeSH terms:

Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012