Actively Recruiting
Liquid Biopsies in Esophageal Adenocarcinoma: Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers
Led by University Hospital, Ghent · Updated on 2024-07-17
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring new RNA biomarkers in the blood to improve early diagnosis of Barrett's esophagus and esophageal adenocarcinoma, aiming to detect these conditions sooner and potentially improve survival rates. This observational study involves analyzing RNA from tissue and plasma samples to identify specific micro RNA and messenger RNA patterns associated with these diseases. The study begins with a proof-of-concept phase involving 20 patients to compare RNA profiles from two types of samples and RNA biotopes using advanced sequencing methods. Following this, a large validation group will confirm the findings, leading to development of a clinical-grade qPCR test. This test will then be evaluated in an independent patient cohort to assess its diagnostic potential. Participants will provide tissue and plasma samples for RNA analysis, allowing researchers to perform detailed data mining and build classifiers for disease detection and therapy response prediction. The primary outcomes include identifying plasma biomarkers over four years and therapy response markers over two years. Secondary outcomes focus on developing a qPCR test within one year. The study includes monitoring for infections, organ function, and other health factors, with a total participation period spanning several years for comprehensive evaluation.
CONDITIONS
Brief Title
Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Barrett's Esophagus longer than 3 cm or histologically confirmed esophageal adenocarcinoma
- Adequate mental ability to understand the study and provide informed consent
- Age over 18 years
- No other current malignant diseases
- Not participating in other clinical trials that interfere with this study
- No ongoing chronic systemic immune or hormone therapy, except for neoadjuvant chemotherapy
- No severe organ failure
- Not pregnant or breastfeeding
- Provided written informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Active bacterial, viral, or fungal infection
- Liver disease including any stage of cirrhosis
- High bleeding risk during biopsy (due to anticoagulants or esophageal varices)
- Esophageal squamous cell carcinoma
- Positive Helicobacter pylori infection at time of biopsy
- History of esophageal radiofrequency ablation
- Psychiatric conditions affecting understanding or judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants provide tissue and plasma samples to identify RNA plasma-based biomarkers for Barrett's Esophagus and esophageal adenocarcinoma.
1 to 2 visits depending on sample collection needs
Duration - Up to 4 years
Participants are monitored over time to validate findings and assess biomarker effectiveness for early detection and therapy response prediction.
Periodic visits for sample collection and assessments
Trial Site Locations
Total: 1 location
1
University hospital Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
P
Piet Pattyn, MD, PhD
A
Annouck Philippron, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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