Barrett's EsophagusEndeavor-1NCT06523374
A Study of Barrett's Esophagus Patients to Investigate Quality of Life and Fear of Cancer, and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer
A study testing Endoscopic brush cytology in people with Barrett's Esophagus and Esophageal Adenocarcinoma, run by University Hospital, Antwerp at 9 sites in 6 countries.
Trial summary
This study serves, in part, to prepare for a future large cohort study. The goal of the study is: 1. The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Esophageal Adenocarcinoma
- What is being tested?
- Endoscopic brush cytology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 13 Aug 2025to Dec 2027
- 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 early esophageal 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 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 chemotherapy or immunotherapy or received chemotherapy < 6 weeks prior to endoscopy
- Undergoing radiotherapy within the esophageal region or received chemotherapy < 6 months prior to endoscopy
- WHO score > 3
Trial locations and contacts
9 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 6 countries
Belgium4 sites, 4 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerpen, 2650
Toon Mertens, +3234368281, toon.mertens@uza.be
Luka Van der Veken, +3234368249, luka.vanderveken@uza.be
- Recruiting
UZ Gent
Ghent, 9000
Dr. David Tate, 0032 9 332 23 00, david.tate@uzgent.be
Dr. David Tate
- Recruiting
AZ Delta
Roeselare, 8800
Dr. Dominiek De Wulf, +32 51 23 72 15
Dr. Dominiek De Wulf
- Recruiting
Sint-Augustinus Hospital (ZAS)
Wilrijk, Antwerpen, 2610
Toon Mertens, +32 34 36 8281, toon.mertens@uza.be
Dr. Thomas Botelberge
Denmark1 site, 1 recruiting
- Recruiting
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, 1 recruiting
- Recruiting
CHU LILLE - Centre Hospitalier Universitaire de Lille
Lille, 59000
Florence Nosal, +33320445751, florence.nosal@chru-lille.fr
Prof. Dr. Guillaume Piessen
Ireland1 site, 1 recruiting
- Recruiting
St James's Hospital
Dublin, D08 NHY1
Prof. Jacintha O'Sullivan, +353 1 8962149, OSULLIJ4@tcd.ie
Prof. Jacintha O Sullivan
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Dr. Federica Ungaro, +39 0226437864, Ungaro.Federica@hsr.it
Dr. Silvio Danese
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Solna, SE-171 76
Dr. Fredrik Klevebro, fredrik.klevebro@regionstockholm.se
Dr. Henrik Maltzman
About this study
Official title: Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early Esophageal Adenocarcinoma for Defining Cost Effective Surveillance Strategies and Prediction of Cancer Recurrence: Prospective Pilot Cohort Study in Preparation of a Randomized Controlled Trial to Determine the Feasibility of a Risk Stratification Model for Barrett Esophagus Patients Based on Brush Cytology, and to Test Novel High Throughput Methods for Assessing Biomarkers for Future Use
This study serves, in part, to prepare for a future large cohort study. The goal of the study is:
- The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis.
- To set up standardized methods for different genetic analyses (DNA-FISH and so-called single cell sequencing) on the 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 high-grade dysplasia or 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 three time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).
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 (4 tubes) will also be collected.
For this study, you will be contacted a total of three times. Once for a screening visit and twice for the sample collection described above. The screening and sample collection will take place during the already scheduled treatments and consultations. Afterwards, 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 three time points during the study.
- Conditions
- Barrett's Esophagus, Esophageal Adenocarcinoma
- Being tested
- Endoscopic brush cytology
- Keywords
- Barrett, Barrett's Esophagus, Endeavor, Esophageal cancer, Esophageal adenocarcinoma
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic brush cytologyProcedure or surgery
A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic brush cytology | Other | Each participant will receive all interventions. A routine endoscopy will be planned during which several minimally invasive interventions will be performed:
drawing a blood sample (standard of care), brush cytology (not standard of care) and biopsies (standard of care) during the endoscopy. Receives: Procedure: Endoscopic brush cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies
We will determine the success rate of obtaining material from different sites for analysis by high throughput technologies (Next Generation Sequencing) of the brush, biopsy or blood samples. A rate of analysable cells of at least 80% of the specimens will be regarded as successful.
Measured: 6-12 months
Success rate of DNA-FISH analyses on the brush cytology samples
Our second primary outcome measure for this pilot study is successful DNA-FISH analysis (successful = at least 50 cells that can be analyzed in at least 80% of participants) on the brush cytology samples for defining the final risk model that will be applied in the randomized controlled trial following the pilot study.
Measured: 6-12 months
Secondary outcomes (5)
Accuracy of a DNA-FISH based risk model
The first secondary outcome is the accuracy of a DNA-FISH based risk model to distinguish low risk from high-risk early Barrett cancers. This will be assessed by endoscopic imaging and histo-pathological outcomes.
Measured: 6-24 months
Correlation of a DNA-FISH based risk model
The correlation of a DNA-FISH based risk model to distinguish low risk from high-risk early Barrett cancers with results obtained from Next Generation Sequencing.
Measured: 6-24 months
Standard operating procedures for specimen collection
A standard operating procedure describing the best method for obtaining brush cytology specimens and for obtaining the right tissue specimens via endoscopy will be created. The best method will be determined by the quality and number of analysable cells.
Measured: 6-24 months
Standard operating procedures for logistical procedures
A standard operating procedure (SOP) for the logistics for shipment, redistribution and storage of patient material and data of the different participating sites will be created based on the course of this pilot study. Interim logistical problems will be spontaneously reported by all sites and resolved with the central team. The final solutions ("best method") will be described in the SOP.
Measured: 6-24 months
Successful participation and answering of questionnaires
The participation and answering of the quality of life questionnaires and anxiety level questionnaires of at least 70% of the patients will be seen as successful.
Measured: 6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start13 Aug 2025
- Primary completionApr 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Universal Diagnostics, Amsterdam UMC, Radboud University Medical Center, AZ Delta, University of Leipzig, IRCCS Ospedale San Raffaele, Karolinska University Hospital, University of Dublin, Trinity College, Heinrich-Heine University, Duesseldorf, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Ghent, Copenhagen University Hospital, Rigshospitalet, Universitätsklinikum Leipzig, St. James's Hospital, Ireland, University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Sheila Krishnadath, Principal investigator, Universitair Ziekenhuis Antwerpen (UZA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523374
- Sponsor's protocol ID
- EDGE3788
- Other IDs
- 101136935
- Acronym
- Endeavor-1
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early Esophageal Adenocarcinoma for Defining Cost Effective Surveillance Strategies and Prediction of Cancer Recurrence: Prospective Pilot Cohort Study in Preparation of a Randomized Controlled Trial to Determine the Feasibility of a Risk Stratification Model for Barrett Esophagus Patients Based on Brush Cytology, and to Test Novel High Throughput Methods for Assessing Biomarkers for Future Use
- ClinicalTrials.gov ID
- NCT06523374
- Acronym / sponsor ID
- Endeavor-1 / EDGE3788
- Conditions
- Barrett's Esophagus, Esophageal Adenocarcinoma
- Keywords
- Barrett, Barrett's Esophagus, Endeavor, Esophageal cancer, Esophageal adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Universal Diagnostics, Amsterdam UMC, Radboud University Medical Center, AZ Delta, University of Leipzig, IRCCS Ospedale San Raffaele, Karolinska University Hospital, University of Dublin, Trinity College, Heinrich-Heine University, Duesseldorf, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Ghent, Copenhagen University Hospital, Rigshospitalet, Universitätsklinikum Leipzig, St. James's Hospital, Ireland, University Hospital, Lille
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jul 2024 (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.
This study serves, in part, to prepare for a future large cohort study. The goal of the study is:
- The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis.
- To set up standardized methods for different genetic analyses (DNA-FISH and so-called single cell sequencing) on the 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 high-grade dysplasia or 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 three time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).
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 (4 tubes) will also be collected.
For this study, you will be contacted a total of three times. Once for a screening visit and twice for the sample collection described above. The screening and sample collection will take place during the already scheduled treatments and consultations. Afterwards, 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 three time points during the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic brush cytology | Other | Procedure: Endoscopic brush cytologyEach participant will receive all interventions. A routine endoscopy will be planned during which several minimally invasive interventions will be performed: drawing a blood sample (standard of care), brush cytology (not standard of care) and biopsies (standard of care) during the endoscopy. |
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 early esophageal Barrett cancer
- Capable of receiving informed consent and of giving permission
- Age 18 and upward
Key exclusion criteria (7 listed)
- Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion
- 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 chemotherapy or immunotherapy or received chemotherapy < 6 weeks prior to endoscopy
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 |
|---|---|---|
| Endoscopic brush cytologyA total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care. | Procedure or surgery | Endoscopic brush cytology |
Primary outcome
Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies
Time frame: 6-12 months
We will determine the success rate of obtaining material from different sites for analysis by high throughput technologies (Next Generation Sequencing) of the brush, biopsy or blood samples. A rate of analysable cells of at least 80% of the specimens will be regarded as successful.
Success rate of DNA-FISH analyses on the brush cytology samples
Time frame: 6-12 months
Our second primary outcome measure for this pilot study is successful DNA-FISH analysis (successful = at least 50 cells that can be analyzed in at least 80% of participants) on the brush cytology samples for defining the final risk model that will be applied in the randomized controlled trial following the pilot study.
5 secondary outcomes
Accuracy of a DNA-FISH based risk model
Time frame: 6-24 months
Correlation of a DNA-FISH based risk model
Time frame: 6-24 months
Standard operating procedures for specimen collection
Time frame: 6-24 months
Standard operating procedures for logistical procedures
Time frame: 6-24 months
Successful participation and answering of questionnaires
Time frame: 6-24 months
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 24 Feb 2026.
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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.
Sheila Krishnadath principal investigator
Universitair Ziekenhuis Antwerpen (UZA)
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic brush cytology in people with Barrett's Esophagus and Esophageal Adenocarcinoma, run by University Hospital, Antwerp at 9 sites in 6 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 7 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Denmark, France, Ireland, Italy and 1 more country. 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 Toon Mertens (+3234368281, Toon.mertens@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies (time frame: 6-12 months). The study lists 2 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 24 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.