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

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ClinicalTrials.gov Identifier: NCT01022723
Recruitment Status : Recruiting
First Posted : December 1, 2009
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
National University, Singapore
Information provided by (Responsible Party):
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.

Condition or disease
Cancer

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 Type : Observational
Estimated Enrollment : 366 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells
Study Start Date : October 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort
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



Primary Outcome Measures :
  1. The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Characteristics and viability of the CTC with this capture method [ Time Frame: 3 years ]
  2. Clinical application of this capture method with the study of CTC titre correlation to treatment outcome [ Time Frame: 6 years ]
  3. Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics [ Time Frame: 6 years ]

Biospecimen Retention:   Samples With DNA
Circulating Tumor Cells


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022723


Contacts
Contact: Lanying Wang, Primary +6564368267 nctwly@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

Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT01022723     History of Changes
Other Study ID Numbers: CTC_ver2_081109
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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