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NCT Number: NCT07455422

A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer

The goal of the study is:

* The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. * To test a risk model based on genetic analyses (DNA-FISH and so-called single cell sequencing) on esophageal tissue samples. * Evaluating the quality of life of Barrett's Esophagus patients and the degree of fear of getting cancer.

Patients with a Barrett's Esophagus can participate in the study if they are minimally 18 years old, are capable of giving informed consent (fully understanding what the study entails before giving consent to participate), have Barrett Esophagus and are referred to one of the participating centers due to suspicion of early esophageal cancer, for which the participant will be evaluated by endoscopic imaging and biopsy.

Study procedures:

An intake consultation will be planned, wherein the eligibility criteria will be assessed, and participant characteristics will be collected.

A routine gastroscopy will be planned twice during which several minimally-invasive interventions will be performed: drawing a blood sample, brush cytology during the endoscopy (a brush is used to obtain cells from the surface of the esophagus) and obtaining biopsy samples (small pieces of tissue). Each participant will need to undergo all the interventions.

Patients will have to complete questionnaires at several time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).

This study is a randomized trial, meaning the study participants will be divided into two groups by the computer. One group will be informed of their risk profile, established based on the genetic analyses. The other group will not be informed of their risk profile. All patients will be followed-up in a more intensive surveillance schedule compared to the standard of care, for study purposes.

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Key information

Conditions

Barrett Esophagus Adenocarcinoma Adenocarcinoma - GEJ Barrett Esophagus Adenocarcinoma Carcinoma Digestive System Diseases Esophageal Diseases Gastroenterological Cancer Gastroenterology Gastrointestinal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital, Edegem, Antwerpen, Belgium

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About this study

More specifically, you will have a standard endoscopy twice during which tissue samples will be taken from the esophagus to check for the severity of the disease. This is part of standard care. If you participate in the study, additional samples will be taken from the esophagus and also from the stomach (a total maximum of 10 samples of 1-2 mm). As a result, the endoscopic examination will take about 10-15 minutes longer than standard. Furthermore, in addition to the tissue samples, cells of the esophageal mucosa will be sampled (through 4 "esophageal brushes") and blood (up to 4 tubes) will also be collected.

For this study, you will be contacted a total of four times. Once for a screening visit and twice for the sample collection described above. One last visite will be planned to discuss the risk profile, depending on the randomization group. After your initial treatment, you will be enrolled in a standard-of-care treatment schedule depending on your specific circumstances. This standard-of-care treatment schedule will coincide with the intensified surveillance schedule to detect recurrence earlier.

Patient outcomes will be documented for the study until a maximum of 5 years after inclusion. This documentation will take place during the routine follow up so does not require any additional visits for the patients. Additionally you will be asked to complete two short questionnaires on your mobile phone at several time points during the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of T1 oesophageal Barrett cancer
  • Capable of receiving informed consent and of giving permission
  • Age 18 and upward

Exclusion criteria

  • Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion
  • Patients refusing randomization and corresponding follow-up intervals based on biomarker profile
  • Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)
  • Esophageal varices
  • Uncontrollable coagulation disorders
  • Undergoing/planned chemotherapy or immunotherapy or received chemotherapy < 6 months prior to endoscopy
  • Undergoing/planned radiotherapy within the esophageal region or received radiotherapy < 6 months prior to endoscopy
  • WHO score >3

Treatment and study plan

Risk profile disclosure

Other

Participants in the intervention arm will be informed by the investigator on their genetic risk profile.

Primary outcomes

  1. Disease recurrence

    Time frame: From endoscopic resection up to three years after endoscopic eradication therapy

    Extraluminal recurrence (regional, distal) of cancer, endoluminal recurrence (metachronous, local) of cancer, endoluminal recurrence of dysplasia

  2. Cancer Worry Scale

    Time frame: After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion

    Cancer Worry Scale (total score, 8-item version) after cessation of endoscopic eradication therapy (EET)

  3. Economic costs

    Time frame: From end of endoscopic eradication therapy until three years after endocsopic eradication therapy

    Economic costs in euro for surveillance programme (including endoscopic procedures, biomarker analysis and materials)

Secondary outcomes

  1. Clonal diversity score

    Time frame: Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)

    Clonal diversity score measurements based on DNA-FISH brush cytology samples before and after endoscopic resection

  2. Disease stage

    Time frame: From patient inclusion until three years after endoscopic eradication therapy

    Disease stage (histopathological disease stage of resection specimen, TNM-classification) based on EMR/ESD, EUS, PET-CT, pathology and cytology

  3. Missing data ePRO

    Time frame: From start of inclusion until three years after endoscopic eradication

    Missing data events for ePRO and paper questionnaires

  4. Caregiver's satisfaction

    Time frame: From start inclusion until three years after endoscopic eradication

    Caregiver's responses to questionnaire on application of biomarker-based health information

  5. Drop-out

    Time frame: From start inclusion until three years after endoscopic eradication

    Drop-out/delay events from allocated endoscopic surveillance, reasons for delays/drop-out

  6. Follow-up years

    Time frame: From end of endoscopic eradication therapy until year three after endoscopic eradication

    Total follow-up years: mean and average follow-up years per patient

  7. Cancer worry scale longitudinal

    Time frame: From start of inclusion until year three after endscopic eradication therapy

    Cancer worry scale total score at predetermined, clinically relevant timepoints

  8. EQ-5D-5L

    Time frame: From start of inclusion until three years after endoscopic eradication

    EQ-5D-5L utility score and Visual Analogue Scale score at predetermined, clinically relevant timepoints

  9. Quality adjusted life years (QALY)

    Time frame: From start of inclusion until three years after endoscopic eradication

    QALY based on clinical endpoints, cancer worry scale results and EQ-5D-5L results

  10. Endoscopy timepoint

    Time frame: From end of endoscopic resection until three years after endoscopic eradication therapy

    Endoscopy timepoint at detected recurrence

  11. Histopathological disease stage

    Time frame: From end of endoscopic resection until three years after endoscopic eradication

    Histopathological disease stage of detected recurrence

  12. Treatment stage recurrence

    Time frame: From endoscopic resection until three years after endocopic eradication

    Treatment stage of detected recurrence (before / during / after RFA)

  13. Mortality events

    Time frame: From endoscopic resection until three years after endoscopic eradication

    Overall and disease-specific mortality events

  14. Number of ablation sessions

    Time frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion

    Amount of ablation sessions needed to achieve CE-IM

  15. Number of CE-IM patients

    Time frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion

    Number of patients that reach CE-IM

  16. Number of RFA therapy-resistant patients

    Time frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion

    Number of RFA therapy-resistant patients defined as >50% residual Barrett Esophagus after first RFA session, or when residual BE is present after cessation of RFA therapy

  17. Local recurrence

    Time frame: From endoscopic resection until three years after endoscopic eradication

    Local recurrence of adenocarcinoma (around the EMR/ESD scar site)

Study contacts

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

Luka Van der Veken, Master Biomedical Sciences

CONTACT

[email protected]

+3234368249

Martin Wyckmans, Resident Physician

CONTACT

[email protected]

+323 821 32 80

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • AZ Delta
  • Amsterdam UMC
  • GZA Ziekenhuizen Campus Sint-Augustinus
  • Heinrich-Heine University, Duesseldorf
  • IRCCS Ospedale San Raffaele
  • Karolinska Institutet
  • Karolinska University Hospital
  • Radbound University Medical Center
  • Rigshospitalet, Denmark
  • St. James's Hospital, Ireland
  • University Hospital, Ghent
  • University Hospital, Lille
  • University of Dublin, Trinity College
  • University of Leipzig
  • Universitätsklinikum Leipzig

Registry information

Official study title

A Randomized Controlled Trial Using Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early ESOPHAGEAL ADENOCARCINOMA for Assessing Effects on Quality of Life, Cancer Worry and Defining Cost-Effective Surveillance Strategies

Acronym: Endeavor-2

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

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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