Clinical trial NCT02812680: The Utility of Circulating Tumour Cells and Plasma microRNA in Esophageal Adenocarcinoma
Official title: The Utility of Circulating Tumour Cells and Plasma microRNA Detection to Predict the Response to Treatment in Patients With Esophageal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Esophageal Cancer Patients vs Healthy Volunteers

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Circulating microRNA (miRNA) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using Human miRNA cards
timeFrame: 2 years
measure: Circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using CTC chips
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Gail E Darling, MD
role: PRINCIPAL_INVESTIGATOR
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