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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by National Cancer Centre, Singapore.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
National University, Singapore
Information provided by (Responsible Party):
Wan-Teck Darren Lim, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT01022723
First received: November 30, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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


Condition
Cancer

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:


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: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lung Cancer patients
Lung Cancer (particular focus on non smokers with adenocarcinoma)
Patients with Nasopharyneal carcinoma
Patients with Nasopharyneal carcinoma
Breast Cancer patients
Breast cancer patients
Prostate Cancer patients
Prostate cancer patients
Colorectal Cancer patients
Colorectal cancer patients
Gastric Cancer patients
Gastric cancer patients

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Lanying Wang, Primary +6564368253 ctewly@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: Wan-Teck Lim, MD National Cancer Centre, Singapore
  More Information

No publications provided

Responsible Party: Wan-Teck Darren Lim, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT01022723     History of Changes
Other Study ID Numbers: CTC_ver2_081109
Study First Received: November 30, 2009
Last Updated: October 17, 2012
Health Authority: Singapore: Health Sciences Authority

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
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014