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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05688176

Enrollment

100

Registered

2023-01-18

Start date

2016-06-30

Completion date

2027-01-31

Last updated

2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms, Liquid biopsy, Transcriptome

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma	4 years	Identification of micro RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Identification of plasma biomarkers (messenger RNAs) for early detection of esophageal adenocarcinoma	4 years	Identification of messenger RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Identification of biomarkers (messenger RNAs) for therapy response prediction	2 years	Identification of a set of messenger RNAs that change during treatment (using longitudinally collected plasma samples) and that separate responders from non-responders to neo-adjuvant radiochemotherapy.

Secondary

Measure	Time frame	Description
Development of a quantitative Polymerase Chain Reaction (qPCR) test for clinical use	1 year	After development and validation on an independent cohort, this test should be evaluated in a second external cohort

Countries

Belgium

Contacts

Primary ContactPiet Pattyn, MD, PhD

piet.pattyn@ugent.be+32 9 332 1295

Backup ContactAnnouck Philippron, MD

annouck.philippron@ugent.be+32 9 332 1531

Outcome results