Esophageal CancerNCT04192695
Esophageal Squamous Cell Cancer Surveillance With Cytosponge
A study testing Cytosponge cell collection device in people with Esophageal Cancer, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Cytosponge cell collection device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 esophageal squamous cell cancer (ESCC):
- Patients ≥18 years of with adequate performance status for endoscopy
- Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth/Chth)
- Patients currently undergoing oncological treatment (Rth/Chth)
- Consent to provide tissue samples for the study
- Dysphagia grade ≤2 (able to swallow mixed foods and tablets)
Show all 12Show fewer
- Patients at high risk for ESCC:
- Patients ≥18 years of age with adequate performance status for endoscopy
- Prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both Rth, Chth, and combination treatment)
- Prior definitive endoscopic treatment for early ESCC in the past (at least 6 months since completion)
- Consent to provide tissue samples for the study
- Dysphagia grade ≤2
Who cannot join
- Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification
- Dysphagia grade ≥3 (able to swallow only liquid foods)
- History of myocardial infarction or other cardiovascular event within 6 months of enrolment
- Neurological diseases associated with impaired swallowing
- Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surveillance and Early Detection of Esophageal Squamous Cell Carcinoma With Minimally-invasive Cytosponge™ Cell Collection Device Coupled With Molecular Biomarkers
Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers.
Read the detailed description
The goal of the study is to identify molecular abnormalities at each developmental stage of esophageal squamous cell carcinoma (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and early squamous cell carcinoma) in order to establish new molecular biomarkers with potential for early detection and surveillance of the disease using the minimally-invasive Cytosponge™ cell collection device. Firstly, tissue samples after endoscopic treatment (endoscopic mucosal resection and endoscopic submucosal dissection) for squamous intraepithelial neoplasia and early squamous cell carcinoma will be analyzed with the use of the next-generation sequencing to identify potential diagnostic biomarkers. Afterward, patients with- and at risk- of esophageal squamous cell carcinoma will be recruited to undergo a diagnostic endoscopy with biopsies (the gold standard) and Cytosponge procedure. The diagnostic accuracy of Cytosponge coupled with molecular biomarkers will be evaluated to compare with the gold standard.
- Conditions
- Esophageal Cancer
- Being tested
- Cytosponge cell collection device
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosponge cell collection deviceDevice
Also called Gastroscopy with biopsies
The Cytosponge™ is a minimally-invasive sampling device consisting of a polyurethane sponge compressed in a cellophane capsule attached to a string. When swallowed, the capsule dissolves in the stomach, releasing the cell collection sponge that expands to 3 cm in diameter. Next, a nurse or qualified medical technician retrieves the sponge by pulling back on the string and retracting it through the mouth. During extraction, the rough texture on the surface of the sponge collects epithelial cells in the cardia and along the entire length of the esophagus. Cytosponge™ has excellent safety profile and is approved by the Food and Drug Administration (FDA) and the Healthcare Products Regulatory Agency (HPRA) in the UK.
| Study group | Role | What they receive |
|---|---|---|
| Cytosponge | Experimental | This part of the study will have an active prospective recruitment of patients. Recruitment will involve two patient populations:
1. Patients with ESCC
2. Patients at high risk for ESCC
Following inclusion in the study, subjects will be asked to complete a behavior questionnaire, have blood collected, and undergo a Cytosponge™ procedure followed by diagnostic gastroscopy using advanced imaging with biopsies. During gastroscopy, additional tissue samples will be collected for research purposes. These samples, along with cytological specimens from the Cytosponge™, will be analyzed to assess the diagnostic accuracy of biomarkers in the diagnosis of LG-IEN, HG-IEN, and ESCC. Receives: Device: Cytosponge cell collection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
RNA-seq expression analysis will be used to measure the abundance of the previously identified biomarkers of squamous intraepithelial neoplasia, including genes TP53, NFE2L2, MLL2, ZNF750, NOTCH1, TFNAIP3, and CHN1. The study will include these biomarkers, but will not be limited to them.
Measured: 4 years
Secondary outcomes (2)
Acceptability of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC
% of Participants that have scored the Cytosponge experience of at least 6 points on a 0 to 10 Visual Analogue Scale (VAS) acceptability scale whereby 0 denotes "worst experience in life" and 10 denotes "best experience in life".
Measured: 4 years
Safety of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC: rate of Participants with adverse events within 30 days after application
The rate of Participants with adverse events within 30 days after application of the Cytosponge cell collection device, which is defined as any event that require admission to the hospital. E.g. retention of the device in the GI tract, chest pain or gastrointestinal bleeding requiring admission to the Ward
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jan 2021
- Primary completion1 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- Model description
- A prospective cohort study
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wladyslaw Januszewicz, Centre of Postgraduate Medical Education
- Investigators
- Wladyslaw Januszewicz, M.D., Principal investigator, Centre of Postgraduate Medical Education, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192695
- Sponsor's protocol ID
- 109/PB/2019
- Status last verified
- May 2024
- First submitted
- 12 Nov 2019
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Turkot MH, Yusuf A, Nowicki-Osuch K, Pilonis ND, Malhotra S, O'Donovan M, Mroz A, Lenarcik M, Wronska E, Mikula M, Zwolinski J, Wojtowicz-Popiel M, di Pietro M, Regula J, Kaminski MF, Fitzgerald RC, Januszewicz W. Feasibility and Diagnostic Accuracy of a Capsule-Sponge Device for Esophageal Squamous Neoplasia (EDEN Trial). Clin Gastroenterol Hepatol. 2026 Sep;24(9):2411-2421. doi: 10.1016/j.cgh.2026.01.025. Epub 2026 Feb 26.
PubMed 41628756
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance and Early Detection of Esophageal Squamous Cell Carcinoma With Minimally-invasive Cytosponge™ Cell Collection Device Coupled With Molecular Biomarkers
- ClinicalTrials.gov ID
- NCT04192695
- Acronym / sponsor ID
- 109/PB/2019
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 10 Dec 2019 (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.
Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers.
Detailed description
The goal of the study is to identify molecular abnormalities at each developmental stage of esophageal squamous cell carcinoma (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and early squamous cell carcinoma) in order to establish new molecular biomarkers with potential for early detection and surveillance of the disease using the minimally-invasive Cytosponge™ cell collection device. Firstly, tissue samples after endoscopic treatment (endoscopic mucosal resection and endoscopic submucosal dissection) for squamous intraepithelial neoplasia and early squamous cell carcinoma will be analyzed with the use of the next-generation sequencing to identify potential diagnostic biomarkers. Afterward, patients with- and at risk- of esophageal squamous cell carcinoma will be recruited to undergo a diagnostic endoscopy with biopsies (the gold standard) and Cytosponge procedure. The diagnostic accuracy of Cytosponge coupled with molecular biomarkers will be evaluated to compare with the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Cytosponge | Experimental | Device: Cytosponge cell collection deviceThis part of the study will have an active prospective recruitment of patients. Recruitment will involve two patient populations: 1. Patients with ESCC 2. Patients at high risk for ESCC Following inclusion in the study, subjects will be asked to complete a behavior questionnaire, have blood collected, and undergo a Cytosponge™ procedure followed by diagnostic gastroscopy using advanced imaging with biopsies. During gastroscopy, additional tissue samples will be collected for research purposes. These samples, along with cytological specimens from the Cytosponge™, will be analyzed to assess the diagnostic accuracy of biomarkers in the diagnosis of LG-IEN, HG-IEN, and ESCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients ≥18 years of with adequate performance status for endoscopy
- Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth/Chth)
- Patients currently undergoing oncological treatment (Rth/Chth)
- Consent to provide tissue samples for the study
- Dysphagia grade ≤2 (able to swallow mixed foods and tablets)
Key exclusion criteria (5 listed)
- Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification
- Dysphagia grade ≥3 (able to swallow only liquid foods)
- History of myocardial infarction or other cardiovascular event within 6 months of enrolment
- Neurological diseases associated with impaired swallowing
- Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).
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 |
|---|---|---|
| Cytosponge cell collection deviceAlso: Gastroscopy with biopsiesThe Cytosponge™ is a minimally-invasive sampling device consisting of a polyurethane sponge compressed in a cellophane capsule attached to a string. When swallowed, the capsule dissolves in the stomach, releasing the cell collection sponge that expands to 3 cm in diameter. Next, a nurse or qualified medical technician retrieves the sponge by pulling back on the string and retracting it through the mouth. During extraction, the rough texture on the surface of the sponge collects epithelial cells in the cardia and along the entire length of the esophagus. Cytosponge™ has excellent safety profile and is approved by the Food and Drug Administration (FDA) and the Healthcare Products Regulatory Agency (HPRA) in the UK. | Device | Cytosponge |
Primary outcome
Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
Time frame: 4 years
RNA-seq expression analysis will be used to measure the abundance of the previously identified biomarkers of squamous intraepithelial neoplasia, including genes TP53, NFE2L2, MLL2, ZNF750, NOTCH1, TFNAIP3, and CHN1. The study will include these biomarkers, but will not be limited to them.
2 secondary outcomes
Acceptability of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC
Time frame: 4 years
Safety of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC: rate of Participants with adverse events within 30 days after application
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41628756Turkot MH, Yusuf A, Nowicki-Osuch K, Pilonis ND, Malhotra S, O'Donovan M, Mroz A, Lenarcik M, Wronska E, Mikula M, Zwolinski J, Wojtowicz-Popiel M, di Pietro M, Regula J, Kaminski MF, Fitzgerald RC, Januszewicz W. Feasibility and Diagnostic Accuracy of a Capsule-Sponge Device for Esophageal Squamous Neoplasia (EDEN Trial). Clin Gastroenterol Hepatol. 2026 Sep;24(9):2411-2421. doi: 10.1016/j.cgh.2026.01.025. Epub 2026 Feb 26.
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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. This study is not recruiting at the moment.
Wladyslaw Januszewicz, M.D. principal investigator
Centre of Postgraduate Medical Education, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosponge cell collection device in people with Esophageal Cancer, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 12 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials. (time frame: 4 years). 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 NCT04192695, which also lists 1 linked publication.
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 8 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.