Searching for RNA biomarkers in Barrett's esophagus and esophageal adenocarcinoma
Liquid Biopsies in Esophageal Adenocarcinoma: Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers
This study is trying to find new RNA markers in blood samples that can help diagnose Barrett's esophagus and esophageal cancer in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT05688176 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with Barrett's esophagus longer than 3 cm or histologically proven esophageal adenocarcinoma.
Not a fit: Patients with active infections, other concurrent malignancies, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis of Barrett's esophagus and esophageal adenocarcinoma, improving patient survival rates.
How similar studies have performed: While the approach of using RNA biomarkers is promising, this specific methodology is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent, Oost-Vlaanderen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.