Therapeutic Response Evaluation by CTC Expansion System

Study Overview
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Brief Summary
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Among biomarkers, CTCs are a convenient, sensitive and biologically informative option. CTC detection could be considered a real-time liquid biopsy approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low, so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this study, we develop a short-term CTC expansion protocol combined with a new surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform, which provides an opportunity to monitor response to therapy noninvasively.

Detailed Description
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CTC detection could be considered a real-time liquid biopsy approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this proposal we will develop a short-term CTC expansion protocol through combine with a new type of surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform which provide an opportunity to noninvasively monitor response to therapy.

Official Title
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Evaluate the Therapeutic Response by Using in Vitro Circulating Tumor Cell Expansion System

Conditions
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Circulating Tumor Cells

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with malignant tumors Exclusion Criteria: Unsuitable for recruitment by clinical judgement or non-compliance with regular follow-up.

Ages Eligible for Study
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Maximum Age: 80 Years

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate drug sensitivity profiles of the expanded circulating tumor cells with the clinical treatment response. | CTC was expanded in vitro culture system and drug sensitivity profile to disease-specific panels was obtained. Clinical treatment response and drug sensitivity profile were analysed with 2 by 2 contingency tables. The evaluation of clinical response rate used by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Briefly, C+ refers to patients with clinical disease control (complete response, partial response, and stable disease), and C- refers to patients were found with worsening diseases (PD). Patients that did not fit into either category were listed as non-evaluable. The drug sensitivity profiles were categorized into E+ and E-. In class E+, at least one chemical in the evaluable treatment regimen was found to kill more than 30% of the cells in the CTC culture system. In class E-, all chemicals in the evaluable treatment regimen were found to kill less than 30% of the cells in the CTC culture system. | CTC was expanded in vitro and drug sensitivity profile to disease-specific panels was obtained. The patient continued with the planned treatment by the treating physician and follow up information was obtained 3 months after blood sampling. |