Submucosal Esophageal AdenocarcinomaPREFERNCT03222635
Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
A study testing Endoscopic follow-up in people with Submucosal Esophageal Adenocarcinoma and Barrett Esophagus, run by Amsterdam UMC at 20 sites in 6 countries.
Trial summary
Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Submucosal Esophageal Adenocarcinoma, Barrett Esophagus, High-risk Mucosal Esophageal Adenocarcinoma
- What is being tested?
- Endoscopic follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 25 Jul 2017to 25 Jul 2028
- 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 submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
- Signed informed consent.
Who cannot join
- Prior history of high-risk mucosal or ≥T1sm.
- Synchronous esophageal squamous cell carcinoma.
- Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.
- Tumor-positive deep resection margin (R1) in ER specimen.
- Patients unable to give signed informed consent.
Trial locations and contacts
20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 6 countries
Netherlands8 sites, 8 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
V. Bos, MD
J. J. Bergman, MD, PhD
- Recruiting
Catharina Hospital
Eindhoven
E. J. Schoon, MD, PhD
E. J. Schoon, MD, PhD
- Recruiting
University Medical Center Groningen
Groningen
W. B. Nagengast, MD, PhD
W. B. Nagengast, MD, PhD
- Recruiting
St. Antonius Hospital
Nieuwegein
B. L. Weusten, MD, PhD
B. L. Weusten, MD, PhD
- Recruiting
Radboudumc
Nijmegen
G. J. Bulte, MD, PhD
- Recruiting
Erasmus MC - University Medical Center
Rotterdam
A. D. Koch, MD, PhD
A. D. Koch, MD, PhD
- Recruiting
Haga Medical Center
The Hague
M. Houben, MD, PhD
M. Houben, MD, PhD
- Recruiting
Isala Clinics
Zwolle
B. E. Schenk, MD, PhD
B. E. Schenk, MD, PhD
Belgium4 sites, 4 recruiting
- Recruiting
CUB Hôpital Erasme
Brussels
Arnaud Lemmers, MD, PhD
- Recruiting
AZ Maria Middelares Ghent
Ghent
P. Dewint, MD, PhD
- Recruiting
UZ Leuven
Leuven
R. Bisschops, MD, PhD
- Recruiting
AZ Delta Roeselare
Roeselare
D. De Wulf, MD, PhD
Germany4 sites, 3 recruiting
- Recruiting
Universitätsklinikum Augsburg
Augsburg
H. Messmann
- Recruiting
EVK Duesseldorf
Düsseldorf
Horst Neuhaus
- Active, not recruiting
MRI TUM
Münich
- Recruiting
Barmherzige Brüder Regensburg
Regensburg
Oliver Pech
United Kingdom2 sites, 2 recruiting
- Recruiting
University College London Hospital
London
R. Haidry, MD, PhD
R. Haidry, MD, PhD
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham
J. Ortiz, MD, PhD
Australia1 site, 1 recruiting
- Recruiting
Westmead hospital
Sydney
M. Bourke, MD, PhD
Switzerland1 site, 1 recruiting
- Recruiting
Hirslanden private hospital group
Zurich
S. Seewald
About this study
Official title: Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.
Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).
Read the detailed description
Traditionally, the risk of lymph node metastasis associated with submucosal EAC was considered too high to offer patients endoscopic follow-up. Only in elderly patients with comorbidity, more often an endoscopic protocol is selected. However, the risk of lymph node metastasis associated with submucosal EAC is mainly based on surgical series. Recently a number of studies, which included patients treated endoscopically, were published indicating that the risk of lymph node metastasis may be much lower than generally assumed (1-5). Therefore, a less invasive and organ preserving approach may not only be an option in the frail and elderly, but for all patients with submucosal EAC's.
Yet, no data exists on the risk of lymph node metastasis in high risk T1a EAC. The risk is assumed to be lower than for EACs invading into the submucosal layer. However, a recent retrospective analysis from our own research group shows that this risk may be higher than previously assumed (6). In this nationwide retrospective study, we analyzed lymph node metastasis rates and EAC related mortality rates concerning patients with high risk T1a, low risk T1b or high risk T1b EAC who received endoscopic treatment. The study was performed in 9 Barrett Expert Centers in the Netherlands (2008-2019). 120 patients were included in the analysis, and results showed the highest lymph node metastasis risk in the high risk T1a patient group.
Aim of this multicenter study is to prospectively evaluate the safety of endoscopic follow-up in patients treated by endoscopic resection for submucosal (T1bN0M0) and high risk mucosal (T1aN0M0) EAC.
High-resolution upper endoscopy with white-light endoscopy and narrow-band imaging supplemented with an EUS are performed every three months during the first two years after ER. After 1 year, a CT-thorax/abdomen will be performed to check for distant metastasis. During the third and fourth year of follow-up, EUS and upper endoscopy are performed every six months. From the fifth year on, EUS and upper endoscopy are performed annually.
- Conditions
- Submucosal Esophageal Adenocarcinoma, Barrett Esophagus, High-risk Mucosal Esophageal Adenocarcinoma
- Being tested
- Endoscopic follow-up
- Keywords
- Barrett's esophagus, Submucosal esophageal adenocarcinoma, Endoscopic treatment, Endoscopic follow-up, High-risk mucosal esophageal adenocarcinoma
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic follow-upProcedure or surgery
Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic follow-up | Experimental | Patients treated with endoscopic resection (ER) for a submucosal or high-risk mucosal esophageal adenocarcinoma without lymphnode- or distant metastases (N0M0) will undergo endoscopic follow-up. Receives: Procedure: Endoscopic follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis)
Disease specific mortality is decribed as mortality directly linked to the esophageal adenocarcinoma (i.e., metastasized EAC, metastasized disease with a simultaneously primary cancer present and it cannot be ruled out (based on histology) that the metastases are related to the other primary cancer, death due to complications of the endoscopic procedure, death due to complications after surgery or CRT, no clear cause of death in patients who have metastases or untreated local recurrence). If patients are diagnosed with distant metastases, and subsequently die of a non-tumor related cause, patients will still be documented as tumor-related death. Will be measured in number of patients and percentages. Survival analysis using Kaplan Meier will be performed.
Measured: 5 years
Overall survival (descriptive statistics in SPSS, percentages, survival analysis)
Overall survival of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
Measured: 5 years
Secondary outcomes (5)
Lymph node metastasis, confirmed by cytology and/or histology (descriptive statistics in SPSS, number of patients (%))
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies.
Measured: 5 years
Local recurrence eligible for endoscopic therapy (descriptive statistics in SPSS, number of patients (%))
In case a local recurrence is found during FU endoscopy, histopathology have to show if it is recurrent cancer.
Measured: 5 years
Local recurrence requiring surgical therapy (descriptive statistics in SPSS, number of patients (%))
In case a local cancer recurrence is not amendable for endoscopic re-treatment, for example due to extensive disease or fibrosis, a patient will be referred for surgery if possible.
Measured: 5 years
Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%))
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.
Measured: 5 years
Quality of life during follow-up endoscopies (questionnaires)
Quality of life is assessed by using questionnaires on set time points during the whole study.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start25 Jul 2017
- Primary completion25 Jul 2028 (estimated)
- Study completion25 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Submucosal Esophageal AdenocarcinomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Upon achieving the designated sample size of 141 patients of the original PREFER-trial, the enrolment of further patients diagnosed with T1b N0M0 EAC and treated endoscopically will be continued as a registration cohort (no sample size) within the same study database. The high-risk T1a group will also continue as a registration cohort, since there is no available data yet to calculate a reliable sample size with. The high-risk T1a patient group will be analysed separately from the T1b patient group.
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacques J.G.H.M. Bergman, Amsterdam UMC, location VUmc
- Investigators
- J. J. Bergman, MD, PhD, Principal investigator, Amsterdam UMCR. E. Pouw, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222635
- Sponsor's protocol ID
- NL6116501817
- Acronym
- PREFER
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2017
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez Herrero L, Pouw RE, van Vilsteren FG, ten Kate FJ, Visser M, van Berge Henegouwen MI, Weusten BL, Bergman JJ. Risk of lymph node metastasis associated with deeper invasion by early adenocarcinoma of the esophagus and cardia: study based on endoscopic resection specimens. Endoscopy. 2010 Dec;42(12):1030-6. doi: 10.1055/s-0030-1255858. Epub 2010 Oct 19.
PubMed 20960392Scholvinck D, Kunzli H, Meijer S, Seldenrijk K, van Berge Henegouwen M, Bergman J, Weusten B. Management of patients with T1b esophageal adenocarcinoma: a retrospective cohort study on patient management and risk of metastatic disease. Surg Endosc. 2016 Sep;30(9):4102-13. doi: 10.1007/s00464-016-5071-y. Epub 2016 Jun 29.
PubMed 27357927Manner H, May A, Pech O, Gossner L, Rabenstein T, Gunter E, Vieth M, Stolte M, Ell C. Early Barrett's carcinoma with "low-risk" submucosal invasion: long-term results of endoscopic resection with a curative intent. Am J Gastroenterol. 2008 Oct;103(10):2589-97. doi: 10.1111/j.1572-0241.2008.02083.x. Epub 2008 Sep 10.
PubMed 18785950Manner H, Pech O, Heldmann Y, May A, Pohl J, Behrens A, Gossner L, Stolte M, Vieth M, Ell C. Efficacy, safety, and long-term results of endoscopic treatment for early stage adenocarcinoma of the esophagus with low-risk sm1 invasion. Clin Gastroenterol Hepatol. 2013 Jun;11(6):630-5; quiz e45. doi: 10.1016/j.cgh.2012.12.040. Epub 2013 Jan 26.
PubMed 23357492Manner H, Pech O, Heldmann Y, May A, Pauthner M, Lorenz D, Fisseler-Eckhoff A, Stolte M, Vieth M, Ell C. The frequency of lymph node metastasis in early-stage adenocarcinoma of the esophagus with incipient submucosal invasion (pT1b sm1) depending on histological risk patterns. Surg Endosc. 2015 Jul;29(7):1888-96. doi: 10.1007/s00464-014-3881-3. Epub 2014 Oct 8.
PubMed 25294553Nieuwenhuis EA, van Munster SN, Meijer SL, Brosens LAA, Jansen M, Weusten BLAM, Alvarez Herrero L, Alkhalaf A, Schenk E, Schoon EJ, Curvers WL, Koch AD, van de Ven SEM, Verheij EPD, Nagengast WB, Westerhof J, Houben MHMG, Tang T, Bergman JJGHM, Pouw RE; Dutch Barrett Expert Centers. Analysis of metastases rates during follow-up after endoscopic resection of early "high-risk" esophageal adenocarcinoma. Gastrointest Endosc. 2022 Aug;96(2):237-247.e3. doi: 10.1016/j.gie.2022.03.005. Epub 2022 Mar 12.
PubMed 35288149
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.
- ClinicalTrials.gov ID
- NCT03222635
- Acronym / sponsor ID
- PREFER / NL6116501817
- Conditions
- Submucosal Esophageal Adenocarcinoma, Barrett Esophagus, High-risk Mucosal Esophageal Adenocarcinoma
- Keywords
- Barrett's esophagus, Submucosal esophageal adenocarcinoma, Endoscopic treatment, Endoscopic follow-up, High-risk mucosal esophageal adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Amsterdam UMCUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 25 Jul 2028 (estimated)
- Study completion
- 25 Jul 2028 (estimated)
- First posted
- 19 Jul 2017 (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.
Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).
Detailed description
Traditionally, the risk of lymph node metastasis associated with submucosal EAC was considered too high to offer patients endoscopic follow-up. Only in elderly patients with comorbidity, more often an endoscopic protocol is selected. However, the risk of lymph node metastasis associated with submucosal EAC is mainly based on surgical series. Recently a number of studies, which included patients treated endoscopically, were published indicating that the risk of lymph node metastasis may be much lower than generally assumed (1-5). Therefore, a less invasive and organ preserving approach may not only be an option in the frail and elderly, but for all patients with submucosal EAC's.
Yet, no data exists on the risk of lymph node metastasis in high risk T1a EAC. The risk is assumed to be lower than for EACs invading into the submucosal layer. However, a recent retrospective analysis from our own research group shows that this risk may be higher than previously assumed (6). In this nationwide retrospective study, we analyzed lymph node metastasis rates and EAC related mortality rates concerning patients with high risk T1a, low risk T1b or high risk T1b EAC who received endoscopic treatment. The study was performed in 9 Barrett Expert Centers in the Netherlands (2008-2019). 120 patients were included in the analysis, and results showed the highest lymph node metastasis risk in the high risk T1a patient group.
Aim of this multicenter study is to prospectively evaluate the safety of endoscopic follow-up in patients treated by endoscopic resection for submucosal (T1bN0M0) and high risk mucosal (T1aN0M0) EAC.
High-resolution upper endoscopy with white-light endoscopy and narrow-band imaging supplemented with an EUS are performed every three months during the first two years after ER. After 1 year, a CT-thorax/abdomen will be performed to check for distant metastasis. During the third and fourth year of follow-up, EUS and upper endoscopy are performed every six months. From the fifth year on, EUS and upper endoscopy are performed annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Upon achieving the designated sample size of 141 patients of the original PREFER-trial, the enrolment of further patients diagnosed with T1b N0M0 EAC and treated endoscopically will be continued as a registration cohort (no sample size) within the same study database. The high-risk T1a group will also continue as a registration cohort, since there is no available data yet to calculate a reliable sample size with. The high-risk T1a patient group will be analysed separately from the T1b patient group.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic follow-up | Experimental | Procedure: Endoscopic follow-upPatients treated with endoscopic resection (ER) for a submucosal or high-risk mucosal esophageal adenocarcinoma without lymphnode- or distant metastases (N0M0) will undergo endoscopic follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Prior history of high-risk mucosal or ≥T1sm.
- Synchronous esophageal squamous cell carcinoma.
- Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.
- Tumor-positive deep resection margin (R1) in ER specimen.
- Patients unable to give signed informed consent.
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 follow-upEndoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds | Procedure or surgery | Endoscopic follow-up |
Primary outcome
5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis)
Time frame: 5 years
Disease specific mortality is decribed as mortality directly linked to the esophageal adenocarcinoma (i.e., metastasized EAC, metastasized disease with a simultaneously primary cancer present and it cannot be ruled out (based on histology) that the metastases are related to the other primary cancer, death due to complications of the endoscopic procedure, death due to complications after surgery or CRT, no clear cause of death in patients who have metastases or untreated local recurrence). If patients are diagnosed with distant metastases, and subsequently die of a non-tumor related cause, patients will still be documented as tumor-related death. Will be measured in number of patients and percentages. Survival analysis using Kaplan Meier will be performed.
Overall survival (descriptive statistics in SPSS, percentages, survival analysis)
Time frame: 5 years
Overall survival of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
5 secondary outcomes
Lymph node metastasis, confirmed by cytology and/or histology (descriptive statistics in SPSS, number of patients (%))
Time frame: 5 years
Local recurrence eligible for endoscopic therapy (descriptive statistics in SPSS, number of patients (%))
Time frame: 5 years
Local recurrence requiring surgical therapy (descriptive statistics in SPSS, number of patients (%))
Time frame: 5 years
Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%))
Time frame: 5 years
Quality of life during follow-up endoscopies (questionnaires)
Time frame: 5 years
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 Jul 2024.
- Background: PubMed 20960392Alvarez Herrero L, Pouw RE, van Vilsteren FG, ten Kate FJ, Visser M, van Berge Henegouwen MI, Weusten BL, Bergman JJ. Risk of lymph node metastasis associated with deeper invasion by early adenocarcinoma of the esophagus and cardia: study based on endoscopic resection specimens. Endoscopy. 2010 Dec;42(12):1030-6. doi: 10.1055/s-0030-1255858. Epub 2010 Oct 19.
- Background: PubMed 27357927Scholvinck D, Kunzli H, Meijer S, Seldenrijk K, van Berge Henegouwen M, Bergman J, Weusten B. Management of patients with T1b esophageal adenocarcinoma: a retrospective cohort study on patient management and risk of metastatic disease. Surg Endosc. 2016 Sep;30(9):4102-13. doi: 10.1007/s00464-016-5071-y. Epub 2016 Jun 29.
- Background: PubMed 18785950Manner H, May A, Pech O, Gossner L, Rabenstein T, Gunter E, Vieth M, Stolte M, Ell C. Early Barrett's carcinoma with "low-risk" submucosal invasion: long-term results of endoscopic resection with a curative intent. Am J Gastroenterol. 2008 Oct;103(10):2589-97. doi: 10.1111/j.1572-0241.2008.02083.x. Epub 2008 Sep 10.
- Background: PubMed 23357492Manner H, Pech O, Heldmann Y, May A, Pohl J, Behrens A, Gossner L, Stolte M, Vieth M, Ell C. Efficacy, safety, and long-term results of endoscopic treatment for early stage adenocarcinoma of the esophagus with low-risk sm1 invasion. Clin Gastroenterol Hepatol. 2013 Jun;11(6):630-5; quiz e45. doi: 10.1016/j.cgh.2012.12.040. Epub 2013 Jan 26.
- Background: PubMed 25294553Manner H, Pech O, Heldmann Y, May A, Pauthner M, Lorenz D, Fisseler-Eckhoff A, Stolte M, Vieth M, Ell C. The frequency of lymph node metastasis in early-stage adenocarcinoma of the esophagus with incipient submucosal invasion (pT1b sm1) depending on histological risk patterns. Surg Endosc. 2015 Jul;29(7):1888-96. doi: 10.1007/s00464-014-3881-3. Epub 2014 Oct 8.
- Background: PubMed 35288149Nieuwenhuis EA, van Munster SN, Meijer SL, Brosens LAA, Jansen M, Weusten BLAM, Alvarez Herrero L, Alkhalaf A, Schenk E, Schoon EJ, Curvers WL, Koch AD, van de Ven SEM, Verheij EPD, Nagengast WB, Westerhof J, Houben MHMG, Tang T, Bergman JJGHM, Pouw RE; Dutch Barrett Expert Centers. Analysis of metastases rates during follow-up after endoscopic resection of early "high-risk" esophageal adenocarcinoma. Gastrointest Endosc. 2022 Aug;96(2):237-247.e3. doi: 10.1016/j.gie.2022.03.005. Epub 2022 Mar 12.
- Individual participant dataSharing planned: No
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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.
J. J. Bergman, MD, PhD principal investigator
Amsterdam UMC
R. E. Pouw, MD, PhD principal investigator
Amsterdam UMC
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic follow-up in people with Submucosal Esophageal Adenocarcinoma and Barrett Esophagus, run by Amsterdam UMC at 20 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 2 inclusion and 5 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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Netherlands, Belgium, Germany, United Kingdom, Australia 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 Vincent Bos, MD (+31204445500, v.bos@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis) (time frame: 5 years). 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?
On the ClinicalTrials.gov record for NCT03222635, which also lists 6 linked publications.
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 Jul 2024.