Barrett EsophagusEndeavor-2NCT07455422
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 study testing Risk profile disclosure in people with Barrett Esophagus and Barrett Esophagus Adenocarcinoma, run by University Hospital, Antwerp at 10 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Barrett Esophagus Adenocarcinoma, Adenocarcinoma - GEJ
- What is being tested?
- Risk profile disclosure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 1 Jun 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 7 countries
Belgium4 sites
Antwerp University Hospital
Edegem, Antwerpen, 2650
Ghent University Hospital (UZ Gent)
Ghent, Belgium, 9000
David Tate, 0032 9 332 23 00, david.tate@uzgent.be
David Tate
AZ Delta
Roeselare, Belgium, 8800
Dominiek Dewulf, +32 51 23 72 15, dominiek.dewulf@azdelta.be
Dominiek Dewulf
Sint-Augustinus Hospital (ZAS)
Wilrijk, Antwerpen, 2610
Martin Wyckmans, +323 821 32 80, martin.wyckmans@uza.be
Thomas Botelberge
Denmark1 site
Rigshospitalet
Copenhagen, 2100
Prof. Dr. Michael Patrick Achiam, +45 35 45 04 41, michael.patrick.achiam.01@regionh.dk
Prof. Dr. Michael Patrick Achiam
France1 site
CHU LILLE - Centre Hospitalier Universitaire de Lille
Lille, 59000
Florence Nosal, +33320445751, florence.nosal@chru-lille.fr
Guillaume Piessen
Germany1 site
University Hospital Leipzig
Leipzig, Leipzig, 04103
Dr. René Thieme, +49 341 97 20809, rene.thieme@medizin.uni-leipzig.de
René Thieme
Ireland1 site
St James's Hospital
Dublin, D08 NHY1
Prof. Jacintha O'Sullivan, +353 1 8962149, OSULLIJ4@tcd.ie
Jessie Elliot
Italy1 site
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Dr. Federica Ungaro, +39 0226437864, Ungaro.Federica@hsr.it
Federica Ungaro
Sweden1 site
Karolinska University Hospital
Solna, SE-171 76
Dr. Fredrik Klevebro, +46-8-585 800 00, fredrik.klevebro@regionstockholm.se
Dr. Henrik Maltzman, henrik.maltzman@regionstockholm.se
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Barrett Esophagus, Barrett Esophagus Adenocarcinoma, Adenocarcinoma - GEJ, Gastroenterology, Gastroenterological Cancer
- Being tested
- Risk profile disclosure
- Keywords
- Barrett Esophagus, Barrett, DNA FISH, Genetic profiling, Adenocarcinoma, Brush cytology, Cancer worry, Disease free survival, Randomized controlled trial, RCT, Endoscopic mucosal resection, Endoscopic submucosal dissection, EMR, ESD, Quality of life, Health-Economic analysis
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk profile disclosureOther
Participants in the intervention arm will be informed by the investigator on their genetic risk profile.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will be informed by the investigator on their genetic risk profile. Receives: Other: Risk profile disclosure |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease recurrence
Extraluminal recurrence (regional, distal) of cancer, endoluminal recurrence (metachronous, local) of cancer, endoluminal recurrence of dysplasia
Measured: From endoscopic resection up to three years after endoscopic eradication therapy
Cancer Worry Scale
Cancer Worry Scale (total score, 8-item version) after cessation of endoscopic eradication therapy (EET)
Measured: After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion
Economic costs
Economic costs in euro for surveillance programme (including endoscopic procedures, biomarker analysis and materials)
Measured: From end of endoscopic eradication therapy until three years after endocsopic eradication therapy
Secondary outcomes (17)
Clonal diversity score
Clonal diversity score measurements based on DNA-FISH brush cytology samples before and after endoscopic resection
Measured: Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)
Disease stage
Disease stage (histopathological disease stage of resection specimen, TNM-classification) based on EMR/ESD, EUS, PET-CT, pathology and cytology
Measured: From patient inclusion until three years after endoscopic eradication therapy
Missing data ePRO
Missing data events for ePRO and paper questionnaires
Measured: From start of inclusion until three years after endoscopic eradication
Caregiver's satisfaction
Caregiver's responses to questionnaire on application of biomarker-based health information
Measured: From start inclusion until three years after endoscopic eradication
Drop-out
Drop-out/delay events from allocated endoscopic surveillance, reasons for delays/drop-out
Measured: From start inclusion until three years after endoscopic eradication
Follow-up years
Total follow-up years: mean and average follow-up years per patient
Measured: From end of endoscopic eradication therapy until year three after endoscopic eradication
Cancer worry scale longitudinal
Cancer worry scale total score at predetermined, clinically relevant timepoints
Measured: From start of inclusion until year three after endscopic eradication therapy
EQ-5D-5L
EQ-5D-5L utility score and Visual Analogue Scale score at predetermined, clinically relevant timepoints
Measured: From start of inclusion until three years after endoscopic eradication
Quality adjusted life years (QALY)
QALY based on clinical endpoints, cancer worry scale results and EQ-5D-5L results
Measured: From start of inclusion until three years after endoscopic eradication
Endoscopy timepoint
Endoscopy timepoint at detected recurrence
Measured: From end of endoscopic resection until three years after endoscopic eradication therapy
Histopathological disease stage
Histopathological disease stage of detected recurrence
Measured: From end of endoscopic resection until three years after endoscopic eradication
Treatment stage recurrence
Treatment stage of detected recurrence (before / during / after RFA)
Measured: From endoscopic resection until three years after endocopic eradication
Mortality events
Overall and disease-specific mortality events
Measured: From endoscopic resection until three years after endoscopic eradication
Number of ablation sessions
Amount of ablation sessions needed to achieve CE-IM
Measured: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Number of CE-IM patients
Number of patients that reach CE-IM
Measured: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Number of RFA therapy-resistant patients
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
Measured: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Local recurrence
Local recurrence of adenocarcinoma (around the EMR/ESD scar site)
Measured: From endoscopic resection until three years after endoscopic eradication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Karolinska University Hospital, Amsterdam UMC, Radboud University Medical Center, University of Leipzig, IRCCS Ospedale San Raffaele, University of Dublin, Trinity College, St. James's Hospital, Ireland, Heinrich-Heine University, Duesseldorf, Copenhagen University Hospital, Rigshospitalet, Universitätsklinikum Leipzig, GZA Ziekenhuizen Campus Sint-Augustinus, AZ Delta, University Hospital, Lille, University Hospital, Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455422
- Sponsor's protocol ID
- CTMS33247
- Other IDs
- 101136935
- Acronym
- Endeavor-2
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07455422
- Acronym / sponsor ID
- Endeavor-2 / CTMS33247
- Conditions
- Barrett Esophagus, Barrett Esophagus Adenocarcinoma, Adenocarcinoma - GEJ, Gastroenterology, Gastroenterological Cancer
- Keywords
- Barrett Esophagus, Barrett, DNA FISH, Genetic profiling, Adenocarcinoma, Brush cytology, Cancer worry, Disease free survival
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Karolinska University Hospital, Amsterdam UMC, Radboud University Medical Center, University of Leipzig, IRCCS Ospedale San Raffaele, University of Dublin, Trinity College, St. James's Hospital, Ireland, Heinrich-Heine University, Duesseldorf, Copenhagen University Hospital, Rigshospitalet, Universitätsklinikum Leipzig, GZA Ziekenhuizen Campus Sint-Augustinus, AZ Delta, University Hospital, Lille, University Hospital, Ghent
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Risk profile disclosureParticipants in the intervention arm will be informed by the investigator on their genetic risk profile. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk profile disclosureParticipants in the intervention arm will be informed by the investigator on their genetic risk profile. | Other | Intervention |
Primary outcome
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
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)
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)
17 secondary outcomes
Clonal diversity score
Time frame: Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)
Disease stage
Time frame: From patient inclusion until three years after endoscopic eradication therapy
Missing data ePRO
Time frame: From start of inclusion until three years after endoscopic eradication
Caregiver's satisfaction
Time frame: From start inclusion until three years after endoscopic eradication
Drop-out
Time frame: From start inclusion until three years after endoscopic eradication
Follow-up years
Time frame: From end of endoscopic eradication therapy until year three after endoscopic eradication
Cancer worry scale longitudinal
Time frame: From start of inclusion until year three after endscopic eradication therapy
EQ-5D-5L
Time frame: From start of inclusion until three years after endoscopic eradication
Quality adjusted life years (QALY)
Time frame: From start of inclusion until three years after endoscopic eradication
Endoscopy timepoint
Time frame: From end of endoscopic resection until three years after endoscopic eradication therapy
Histopathological disease stage
Time frame: From end of endoscopic resection until three years after endoscopic eradication
Treatment stage recurrence
Time frame: From endoscopic resection until three years after endocopic eradication
Mortality events
Time frame: From endoscopic resection until three years after endoscopic eradication
Number of ablation sessions
Time frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
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 RFA therapy-resistant patients
Time frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Local recurrence
Time frame: From endoscopic resection until three years after endoscopic eradication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Endeavor EU WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Barrett Esophagus
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk profile disclosure in people with Barrett Esophagus and Barrett Esophagus Adenocarcinoma, run by University Hospital, Antwerp at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Denmark, France, Germany, Ireland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Wyckmans, Resident Physician (+323 821 32 80, martin.wyckmans@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease recurrence (time frame: From endoscopic resection up to three years after endoscopic eradication therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.