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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688176
• Other study ID #: B670201628319
• Status: Recruiting
• Start date: June 2016
• Est. completion date: January 31, 2027

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: Piet Pattyn, MD, PhD
• Phone: +32 9 332 1295
• Email: piet.pattyn[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Neoplasms

Locations

Country	Name	City	State
Belgium	University hospital Ghent	Ghent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma	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).	4 years
Primary	Identification of plasma biomarkers (messenger RNAs) for early detection of esophageal adenocarcinoma	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).	4 years
Primary	Identification of biomarkers (messenger RNAs) for therapy response prediction	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.	2 years
Secondary	Development of a quantitative Polymerase Chain Reaction (qPCR) test for clinical use	After development and validation on an independent cohort, this test should be evaluated in a second external cohort	1 year