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Completed

NCT Number: NCT02812680

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Other

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.

Primary outcomes

  1. Circulating microRNA (miRNA) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using Human miRNA cards

    Time frame: 2 years

  2. Circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using CTC chips

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2016
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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