Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

This study is designed to perform a explorative search of the transcriptome to detect new circulating diagnostic sensitive and specific biomarkers in patients with Barrett's esophagus or esophageal adenocarcinoma.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Barrett's Esophagus with length > 3cm OR esophageal adenocarcinoma histologically proven

Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent

Age over 18 years

No other concurrent malignant disease

Disqualifiers

Pregnancy or breast feeding

Active bacterial, viral or fungal infection

Parenchymal liver disease (any stage cirrhosis)

High risk of bleeding during biopsy (anticoagulants, esophageal varices)

Trial population

All patients diagnosed with Barrett oesophagus or esophageal adenocarcinoma who meet the eligibility criteria are candidates for inclusion in this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma

Identification of micro RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).

Time frame
4 years
2

Identification of plasma biomarkers (messenger RNAs) for early detection of esophageal adenocarcinoma

Identification of messenger RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).

Time frame
4 years
3

Identification of biomarkers (messenger RNAs) for therapy response prediction

Identification of a set of messenger RNAs that change during treatment (using longitudinally collected plasma samples) and that separate responders from non-responders to neo-adjuvant radiochemotherapy.

Time frame
2 years

Secondary outcomes

1

Development of a quantitative Polymerase Chain Reaction (qPCR) test for clinical use

After development and validation on an independent cohort, this test should be evaluated in a second external cohort

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborator