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

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

NCT ID: NCT05688176

Condition: Esophageal Neoplasms

Conditions: Official terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms

Conditions: Keywords:
Esophageal Neoplasms
Liquid biopsy
Transcriptome

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: 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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University hospital Ghent

Address:
City: Ghent
Zip: 9000
Country: Belgium

Status: Recruiting

Contact:
Last name: Piet Pattyn, MD, PhD

Phone: +32 9 332 1295
Email: piet.pattyn@ugent.be

Contact backup:
Last name: Annouck Philippron, MD

Phone: +32 9 332 1531
Email: annouck.philippron@ugent.be

Start date: June 2016

Completion date: January 31, 2027

Lead sponsor:
Agency: University Hospital, Ghent
Agency class: Other

Collaborator:
Agency: Universitaire Ziekenhuizen KU Leuven
Agency class: Other

Source: University Hospital, Ghent

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05688176