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Recruiting NCT05688176

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

— Observational Esophageal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Esophageal Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

By developing new tools for risk-assessing of Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) in a population at risk, the investigators expect that diagnosis can be done in an earlier stage resulting in an improved 5-year survival. A proof-of-concept RNA profiling study will be done in 20 BE and EAC patients where 2 biomaterials (tissue and plasma) and 2 RNA biotopes (micro RNA and messenger RNA) will be compared. Previously validated methodology on small RNA and messenger RNA capture sequencing on both tissue and plasma will be used to obtain high-quality data. Differential expression analysis will be done on tissue and plasma sample data. Additional in-depth data-mining will be done, amongst other focusing on structural information encoded in the transcriptome and building a multifeature classifier. These findings will be validated in a large validation cohort, followed by development of a clinical-grade quantitative Polymerase Chain Reaction (qPCR) test, ready for testing in an independent cohort.

Primary outcome measures

  • Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma [Time frame: 4 years]
  • Identification of plasma biomarkers (messenger RNAs) for early detection of esophageal adenocarcinoma [Time frame: 4 years]
  • Identification of biomarkers (messenger RNAs) for therapy response prediction [Time frame: 2 years]
Secondary outcome measures (1)
  • Development of a quantitative Polymerase Chain Reaction (qPCR) test for clinical use [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • University hospital Ghent — Ghent

Identifiers

NCT: NCT05688176 · B670201628319

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗