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

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

Detailed Description
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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

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

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung Cancer patients<br>Lung Cancer (particular focus on non smokers with adenocarcinoma) | |
| Patients with Nasopharyneal carcinoma<br>Patients with Nasopharyneal carcinoma | |
| Breast Cancer patients<br>Breast cancer patients | |
| Prostate Cancer patients<br>Prostate cancer patients | |
| Colorectal Cancer patients<br>Colorectal cancer patients | |
| Gastric Cancer patients<br>Gastric cancer patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics |  | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating tumor cells, metastasis, cancer, cell isolation, mircofludics, cell detection