Cancer Clinical Trial
— CTCOfficial title:
Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells
| NCT number | NCT01022723 |
| Other study ID # | CTC_ver2_081109 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2009 |
| Est. completion date | December 2018 |
To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.
| Status | Recruiting |
| Enrollment | 817 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| Singapore | National Cancer Centre | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Centre, Singapore | National Medical Research Council (NMRC), Singapore, National University, Singapore |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Characteristics and viability of the CTC with this capture method | 3 years | ||
| Secondary | Clinical application of this capture method with the study of CTC titre correlation to treatment outcome | 6 years | ||
| Secondary | Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics | 6 years |
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