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Trial record 8 of 14 for:    15761078 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02812680
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment
Esophageal Cancer Other: Blood Draw

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Utility of Circulating Tumour Cells and Plasma microRNA Detection to Predict the Response to Treatment in Patients With Esophageal Adenocarcinoma
Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Esophageal Cancer Patients - Blood Draw
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
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.

Healthy volunteers - Blood Draw
Comparators for the esophageal cancer group
Other: Blood Draw
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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Esophageal Cancer Patients vs Healthy Volunteers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812680


Contacts
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Contact: Frances Allison 416-340-5446 frances.allison@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Frances Allison    416-340-5446    frances.allison@uhn.ca   
Principal Investigator: Gail E Darling, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Gail E Darling, MD University Health Network, Toronto

Additional Information:
Publications:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02812680     History of Changes
Other Study ID Numbers: 15-9303-CE
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplastic Cells, Circulating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes