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NCT07455422: Endeavor-2
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
NA trial testing Risk profile disclosure in Barrett Esophagus in 266 participants. Not yet recruiting.
31 December 2030
Quick facts
| Lead sponsor | University Hospital, Antwerp |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 266 |
| Start date | 1 June 2026 |
| Primary completion | 31 December 2030 |
| Estimated completion | 31 December 2030 |
| Sites | 10 locations across Denmark, France, Italy, Belgium, Sweden, Ireland, Germany |
Drugs / interventions tested
- Risk profile disclosure
Conditions studied
- Barrett Esophagus — all drugs for Barrett Esophagus →
- Barrett Esophagus Adenocarcinoma — all drugs for Barrett Esophagus Adenocarcinoma →
- Adenocarcinoma - GEJ — all drugs for Adenocarcinoma - GEJ →
- Gastroenterology — all drugs for Gastroenterology →
Sponsor
University Hospital, Antwerp
Who can join
18 and older, any sex, with Barrett Esophagus or Barrett Esophagus Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07455422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Barrett Esophagus
Currently open trials in the same condition.
- NCT07126535 — Impact of RFA on Esophageal Distensibility and Mucosal Impedance · recruiting
- NCT06746623 — Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux · NA · recruiting
- NCT06687603 — Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms · NA · recruiting
- NCT06803147 — "Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillan · recruiting
- NCT06693622 — Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests · recruiting
Other University Hospital, Antwerp trials
Trials by the same sponsor.
- NCT07020715 — A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis · Phase 2 · not yet recruiting
- NCT07443761 — Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital. · active not recruiting
- NCT06372847 — DISE-HNS Effect Study · NA · recruiting
- NCT07189091 — CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS · Phase 4 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07455422 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Antwerp
- Last refreshed: 6 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07455422.
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