Barrett EsophagusBENCT00431756
Novel Biomarkers in the Neoplastic Progression of Barrett's Esophagus
An observational study of Barrett Esophagus and Esophageal Neoplasm, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine if there are any early changes in DNA markers of blood and esophageal tissue in people with gastric reflux, Barrett's esophagus or esophageal cancer that can warn of a progression to esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Esophageal Neoplasm, Gastroesophageal Reflux
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2002to 31 Aug 2027
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People scheduled for endoscopy at Johns Hopkins who have esophageal cancer, Barrett's esophagus or gastro-esophageal reflux disease
Who may be able to join
- People who are undergoing upper endoscopy as part of their medical care with a history of esophageal cancer, Barrett's esophagus, or upper gastrointestinal symptoms.
Who cannot join
- People who are are currently having chemotherapy, or who have completed chemotherapy within the last 4 weeks.
- People who have ever had radiation treatments to their chest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Biomarkers in the Neoplastic Progression of Barrett's Esophagus (Previously: Methylation in Cancer Progression of Barrett's Esophagus
The purpose of this study is to determine if there are any early changes in DNA markers of blood and esophageal tissue in people with gastric reflux, Barrett's esophagus or esophageal cancer that can warn of a progression to esophageal cancer.
Read the detailed description
Patients with Barrett's esophagus (BE) have an increased risk of esophageal adenocarcinoma which is 40-125 fold higher than in the general population. However, the current techniques of detecting dysplasia and observing abnormal p53 immunohistochemical staining are not accurate or reliable methods for determining which BE patients will progress to cancer. DNA hypermethylation is an epigenetic process that occurs in the promoter region of certain genes, resulting in suppression of gene expression. Inactivation of specific genes via hypermethylation has been highly associated with cancer.
The primary objective of this research is to determine whether DNA hypermethylation is a biomarker that will predict which patients with BE are likely to progress to adenocarcinoma. Patients with BE and/or esophageal adenocarcinoma who undergo endoscopy at the Johns Hopkins Hospital will comprise the cohort of subjects. Gene hypermethylation will be assessed by performing methylation-specific Polymerase Chain Reaction (PCR) on a panel of 8 cancer-related genes.
Specific Aim 1: To compare the prevalence of gene hypermethylation in BE patients with different grades of dysplasia and/or adenocarcinoma, using archived specimens.
Specific Aim 2: To determine whether the presence of gene hypermethylation in initial biopsies of BE patients is associated with progression to adenocarcinoma, using archived specimens. To compare gene hypermethylation with currently available markers for neoplastic progression.
Specific Aim 3: To determine whether methylated DNA from BE and/or adenocarcinoma can be detected in the peripheral blood of patients, by comparing methylation profiles of esophageal biopsy specimens with peripheral blood samples taken at the same time in prospectively enrolled patients.
If hypermethylation of one or more genes is detected at an early stage in BE patients who later progress to adenocarcinoma, hypermethylation could be used as an early predictor for adenocarcinoma even before pathologic changes are evident. Furthermore, this research will help determine the specific genetic events that occur in the neoplastic transformation from BE to adenocarcinoma.
The long-term goal of this project is to determine whether hypermethylation can identify BE patients who are at high risk for neoplastic progression, thus allowing for early intervention in the form of more frequent endoscopic surveillance, chemoprevention, ablative therapy, or surgery.
- Keywords
- Barrett's esophagus, gastroesophageal reflux disease (GERD), esophageal cancer, DNA methylation
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms, Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
early predictors of esophageal cancer
To see if changes in certain areas of DNA can predict risk for esophageal cancer
Measured: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study start1 May 2002
- Primary completion1 May 2023
- Study completion31 Aug 2027 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marcia Canto, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431756
- Sponsor's protocol ID
- IRB00026956
- Other IDs
- 1K23DK068149
- Acronym
- BE
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2007
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers in the Neoplastic Progression of Barrett's Esophagus (Previously: Methylation in Cancer Progression of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT00431756
- Acronym / sponsor ID
- BE / IRB00026956
- Keywords
- Barrett's esophagus, gastroesophageal reflux disease (GERD), esophageal cancer, DNA methylation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
- Study start
- 1 May 2002 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Feb 2007 (estimated)
- 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 purpose of this study is to determine if there are any early changes in DNA markers of blood and esophageal tissue in people with gastric reflux, Barrett's esophagus or esophageal cancer that can warn of a progression to esophageal cancer.
Detailed description
Patients with Barrett's esophagus (BE) have an increased risk of esophageal adenocarcinoma which is 40-125 fold higher than in the general population. However, the current techniques of detecting dysplasia and observing abnormal p53 immunohistochemical staining are not accurate or reliable methods for determining which BE patients will progress to cancer. DNA hypermethylation is an epigenetic process that occurs in the promoter region of certain genes, resulting in suppression of gene expression. Inactivation of specific genes via hypermethylation has been highly associated with cancer.
The primary objective of this research is to determine whether DNA hypermethylation is a biomarker that will predict which patients with BE are likely to progress to adenocarcinoma. Patients with BE and/or esophageal adenocarcinoma who undergo endoscopy at the Johns Hopkins Hospital will comprise the cohort of subjects. Gene hypermethylation will be assessed by performing methylation-specific Polymerase Chain Reaction (PCR) on a panel of 8 cancer-related genes.
Specific Aim 1: To compare the prevalence of gene hypermethylation in BE patients with different grades of dysplasia and/or adenocarcinoma, using archived specimens.
Specific Aim 2: To determine whether the presence of gene hypermethylation in initial biopsies of BE patients is associated with progression to adenocarcinoma, using archived specimens. To compare gene hypermethylation with currently available markers for neoplastic progression.
Specific Aim 3: To determine whether methylated DNA from BE and/or adenocarcinoma can be detected in the peripheral blood of patients, by comparing methylation profiles of esophageal biopsy specimens with peripheral blood samples taken at the same time in prospectively enrolled patients.
If hypermethylation of one or more genes is detected at an early stage in BE patients who later progress to adenocarcinoma, hypermethylation could be used as an early predictor for adenocarcinoma even before pathologic changes are evident. Furthermore, this research will help determine the specific genetic events that occur in the neoplastic transformation from BE to adenocarcinoma.
The long-term goal of this project is to determine whether hypermethylation can identify BE patients who are at high risk for neoplastic progression, thus allowing for early intervention in the form of more frequent endoscopic surveillance, chemoprevention, ablative therapy, or surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People scheduled for endoscopy at Johns Hopkins who have esophageal cancer, Barrett's esophagus or gastro-esophageal reflux disease
Key inclusion criteria (1 listed)
- People who are undergoing upper endoscopy as part of their medical care with a history of esophageal cancer, Barrett's esophagus, or upper gastrointestinal symptoms.
Key exclusion criteria (2 listed)
- People who are are currently having chemotherapy, or who have completed chemotherapy within the last 4 weeks.
- People who have ever had radiation treatments to their chest.
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
early predictors of esophageal cancer
Time frame: 3
To see if changes in certain areas of DNA can predict risk for esophageal cancer
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 26 Aug 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. This study is not recruiting at the moment.
Marcia Canto, M.D. principal investigator
Johns Hopkins University
1 site 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 Neoplasm, run by Johns Hopkins University at 1 site 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. 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 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?
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?
early predictors of esophageal cancer (time frame: 3). 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 26 Aug 2026.