The Utility of Circulating Tumour Cells and Plasma microRNA in Esophageal Adenocarcinoma

Study Overview
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Brief Summary
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Circulating microRNA (circ miRNA) and circulating tumor cell (CTC) levels are hypothesized to be associated with response to chemoradiation in patients undergoing treatment for locally advanced esophageal adenocarcinoma. The goal of this project is to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.

Detailed Description
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Recently, different groups have discovered that miRNAs can be detected in body fluids such as plasma, serum or saliva. These cell-free miRNAs are secreted by cells under different forms. Levels of these circulating miRNAs (circ miRNA), like tissue miRNA, were closely related to pathologies and could be used as diagnostic or prognostic tools for several pathologies, including cancer. Furthermore, a recent report showed that circ miRNAs released by tumor cells have the ability to transfer their metastatic potential to nonmetastatic cells. The detection and analysis of circulating miRNA represent a new step towards non-invasive diagnostic screening and early cancer detection. Circulating tumor cells also hold promise as biological markers, which can be assessed noninvasively. As more than 90% of cancer deaths are associated with metastasis, it is crucial to understand the mechanisms of dissemination of cancer cells. During the past decade, a multitude of techniques have been developed to track down and to characterize CTC. Clinical studies in various cancers reveal the potential of CTC as prognostic and predictive markers. The characterization of CTC will help to design personalized treatment to eradicate the sub-clones of the primary tumour, which give rise to metastasis. Also, the numbers of CTC in patient blood can be followed to monitor the efficacy of the neoadjuvant treatment. Most of the research in esophageal cancer has been done on squamous cell cancer as this is the dominant cell type worldwide. However, beginning the in 1980s Esophageal Adenocarcinoma (EAC) has increased in frequency such that it now represents 80% of esophageal cancer in North America and Europe. There is an urgent need to develop new techniques and diagnostic tests to combat EAC. By combining circ miRNA and CTC, we not only combine 2 promising clinical biomarkers, we will also be able to access new data that will complement tissue biopsy data. Furthermore, by acquiring a blood sample during various time points of patient treatment, we will be able to create a dynamic CTC and circ miRNA profile.

Official Title
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The Utility of Circulating Tumour Cells and Plasma microRNA Detection to Predict the Response to Treatment in Patients With Esophageal Adenocarcinoma

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Other: Blood Draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are at least 18 years of age Patients with Esophageal Adenocarcinoma who will undergo neo-adjuvant therapy with surgical resection. Patients with esophageal adenocarcinoma who will be treated with chemotherapy, chemotherapy and radiation or radiation alone OR Healthy volunteers who are at least 18 years of age Exclusion Criteria: Patients who are treated with surgery alone for esophageal cancer Patients who have a history of invasive cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Esophageal Cancer Patients - Blood Draw<br>Look at blood samples to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy in patients with Esophageal Adenocarcinoma. | Other: Blood Draw<br>* Blood draw to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.<br>|
| Healthy volunteers - Blood Draw<br>Comparators for the esophageal cancer group | Other: Blood Draw<br>* Blood draw to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating microRNA (miRNA) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using Human miRNA cards |  | 2 years | 
| Circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using CTC chips |  | 2 years |