Searching for RNA biomarkers in Barrett's esophagus and esophageal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the transcriptome to identify new circulating RNA biomarkers that can aid in the diagnosis of Barrett's esophagus and esophageal adenocarcinoma. It will involve a proof-of-concept analysis comparing tissue and plasma samples from 20 patients, utilizing advanced RNA capture sequencing techniques. The goal is to develop a multifeature classifier for risk assessment and to validate findings in a larger cohort, ultimately leading to a clinical-grade qPCR test for early diagnosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy
* Absence of any severe organ insufficiency
* No pregnancy or breast feeding
* Written informed consent

Exclusion Criteria:

* 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)
* Esophageal squamous cell carcinoma
* Helicobacter pylori positive at the time of biopsy sampling
* Radiofrequency ablation of the oesophagus
* Psychiatric pathology capable of affecting comprehension and judgement faculty

Where it's running

• University hospital Ghent
  Ghent, Oost-Vlaanderen, Belgium Recruiting

Study contacts

• Principal investigator: Piet Pattyn, MD, PhD — University Hospital, Ghent
• Study coordinator: Piet Pattyn, MD, PhD
• Email: piet.pattyn@ugent.be
• Phone: +32 9 332 1295

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.