Barrett EsophagusNCT04214119
EsophaCap for the Detection of Early Esophageal Carcinoma
An observational study of Barrett Esophagus and Esophageal Cancer, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Esophageal Cancer, Gastric Cancer
- How many people
- 2,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jan 2016to 19 Dec 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study.
Who may be able to join
- Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1/2016 to 12/2025
- Age greater than 18 years
- Patients must be able to swallow a capsule
Who cannot join
- Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer
- Patients who have undergone esophagectomy
- Patients who have undergone radiation to the chest
- Patients who are younger than 18
- Patients with esophageal stents
- Patients with esophageal strictures disabling passage of the capsule
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Bayview Medical Center
Baltimore, Maryland, 21205
Stephen J Meltzer, M.D., 410-502-6071, smeltzer@jhmi.edu
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Stephen Meltzer, M.D., 410-502-6071, smeltzer@jhmi.edu
About this study
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.
Read the detailed description
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma). Esophageal and gastric cytology will be collected via sponge capsule. Candidate genes will be tested with DNA isolated from these samples in order to identify optimal biomarkers to differentiate between Barrett's esophagus and esophageal/gastric cancer versus normal esophageal/gastric tissue.
- Conditions
- Barrett Esophagus, Esophageal Cancer, Gastric Cancer
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients age 18 or greater who have undergone esophagogastroduodenoscopy and does not have a diagnosis of Barrett's esophagus or esophageal/gastric malignancy. | |
| Barrett's esophagus | Patients age 18 or greater who have undergone esophagogastroduodenoscopy and diagnosed with Barrett's esophagus via pathology. | |
| Esophageal carcinoma | Patients age 18 or greater who have diagnosis of primary esophageal carcinoma. | |
| Gastric cancer | Patients age 18 or greater who have diagnosis of primary esophageal cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue.
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in Barrett's esophagus versus control in order to differentiate between subjects who have Barrett's esophagus and those who do not have Barrett's esophagus. This is measure using methylation index and the calculated probability score from different methylation index values.
Measured: 1 day
Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue.
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in esophageal cancer versus control in order to differentiate between subjects who have esophageal cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.
Measured: 1 day
Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue.
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in gastric cancer versus control in order to differentiate between subjects who have gastric cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.
Measured: 1 day
Secondary outcomes (10)
Sensitivity of candidate biomarker p16
Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Sensitivity of candidate biomarker NELL1
Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Sensitivity of candidate biomarker AKAP12
Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Sensitivity of candidate biomarker TAC1
Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Sensitivity of candidate biomarker HPP1
Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Specificity of candidate biomarker p16
Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Specificity of candidate biomarker NELL1
Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Specificity of candidate biomarker AKAP12
Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Specificity of candidate biomarker TAC1
Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Specificity of candidate biomarker HPP1
Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start12 Jan 2016
- Primary completion19 Dec 2028 (estimated)
- Study completion19 Dec 2028 (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 Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Meltzer, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214119
- Sponsor's protocol ID
- IRB00072332
- Other IDs
- R01DK118250
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EsophaCap for the Detection of Early Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT04214119
- Acronym / sponsor ID
- IRB00072332
- Conditions
- Barrett Esophagus, Esophageal Cancer, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 19 Dec 2028 (estimated)
- Study completion
- 19 Dec 2028 (estimated)
- First posted
- 2 Jan 2020 (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 is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.
Detailed description
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma). Esophageal and gastric cytology will be collected via sponge capsule. Candidate genes will be tested with DNA isolated from these samples in order to identify optimal biomarkers to differentiate between Barrett's esophagus and esophageal/gastric cancer versus normal esophageal/gastric tissue.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients age 18 or greater who have undergone esophagogastroduodenoscopy and does not have a diagnosis of Barrett's esophagus or esophageal/gastric malignancy. |
| Barrett's esophagus | – | –Patients age 18 or greater who have undergone esophagogastroduodenoscopy and diagnosed with Barrett's esophagus via pathology. |
| Esophageal carcinoma | – | –Patients age 18 or greater who have diagnosis of primary esophageal carcinoma. |
| Gastric cancer | – | –Patients age 18 or greater who have diagnosis of primary esophageal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study.
Key inclusion criteria (3 listed)
- Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1/2016 to 12/2025
- Age greater than 18 years
- Patients must be able to swallow a capsule
Key exclusion criteria (6 listed)
- Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer
- Patients who have undergone esophagectomy
- Patients who have undergone radiation to the chest
- Patients who are younger than 18
- Patients with esophageal stents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue.
Time frame: 1 day
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in Barrett's esophagus versus control in order to differentiate between subjects who have Barrett's esophagus and those who do not have Barrett's esophagus. This is measure using methylation index and the calculated probability score from different methylation index values.
Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue.
Time frame: 1 day
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in esophageal cancer versus control in order to differentiate between subjects who have esophageal cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.
Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue.
Time frame: 1 day
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in gastric cancer versus control in order to differentiate between subjects who have gastric cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.
10 secondary outcomes
Sensitivity of candidate biomarker p16
Time frame: 1 day
Sensitivity of candidate biomarker NELL1
Time frame: 1 day
Sensitivity of candidate biomarker AKAP12
Time frame: 1 day
Sensitivity of candidate biomarker TAC1
Time frame: 1 day
Sensitivity of candidate biomarker HPP1
Time frame: 1 day
Specificity of candidate biomarker p16
Time frame: 1 day
Specificity of candidate biomarker NELL1
Time frame: 1 day
Specificity of candidate biomarker AKAP12
Time frame: 1 day
Specificity of candidate biomarker TAC1
Time frame: 1 day
Specificity of candidate biomarker HPP1
Time frame: 1 day
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 16 Dec 2025.
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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.
Stephen Meltzer, M.D. principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Esophageal Cancer, run by Johns Hopkins University at 2 sites in United States.
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 6 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Stephen J Meltzer, M.D. (4105026071, smeltzer@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue. (time frame: 1 day). 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 16 Dec 2025.