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NCT Number: NCT05688176

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma

    Time frame: 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).

  2. Identification of plasma biomarkers (messenger RNAs) for early detection of esophageal adenocarcinoma

    Time frame: 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).

  3. Identification of biomarkers (messenger RNAs) for therapy response prediction

    Time frame: 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 outcomes

  1. Development of a quantitative Polymerase Chain Reaction (qPCR) test for clinical use

    Time frame: 1 year

    After development and validation on an independent cohort, this test should be evaluated in a second external cohort

Study contacts

Contact information is provided by the study sponsor or research team.

Annouck Philippron, MD

CONTACT

[email protected]

+32 9 332 1531

Piet Pattyn, MD, PhD

CONTACT

[email protected]

+32 9 332 1295

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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