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

NCT ID: NCT05688176

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2027-01-31

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.

Conditions

Esophageal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piet Pattyn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

University hospital Ghent

Ghent, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Piet Pattyn, MD, PhD

Role: CONTACT

piet.pattyn@ugent.be

+32 9 332 1295

Annouck Philippron, MD

Role: CONTACT

annouck.philippron@ugent.be

+32 9 332 1531

Facility Contacts

Piet Pattyn, MD, PhD

Role: primary

piet.pattyn@ugent.be

+32 9 332 1295

Annouck Philippron, MD

Role: backup

annouck.philippron@ugent.be

+32 9 332 1531

Other Identifiers

B670201628319

Identifier Type: -

Identifier Source: org_study_id