Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma - GEJ | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Barrett Esophagus | — | UNRESOLVED | — |
| Barrett Esophagus Adenocarcinoma | — | UNRESOLVED | — |
| Gastroenterological Cancer | — | UNRESOLVED | — |
| Gastroenterology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Risk profile disclosure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Participants in the intervention arm will be informed by the investigator on their genetic risk profile.
- interventionNames
- Other: Risk profile disclosure
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants in the control arm will not be informed by the investigator on their genetic risk profile. Both the participant and the investigator are not aware of the genetic risk profile.
Primary outcomes (3)
- measure
- Disease recurrence
- timeFrame
- From endoscopic resection up to three years after endoscopic eradication therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available