Barrett's EsophagusNCT01787864
Prevalence of Dysplasia of the Gastric Cardia
An observational study of Barrett's Esophagus and Intestinal Metaplasia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
We propose a tissue sample collection study for patients at UNC who have undergone or will undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal adenocarcinoma as part of routine medical care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus, Intestinal Metaplasia, Intramucosal Adenocarcinoma
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2017
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will consist of a cross-sectional arm, as well as a prospective longitudinal arm, and will include patients who are undergoing ablative therapy at UNC. The cross-sectional arm will consist of patients who have undergone ablative therapy for Barrett's Esophagus (BE) and have had at least one clear pathology report with no evidence of BE since their first ablation. Concurrently enrolled will be a prospective longitudinal arm which will consist of patients prior to their first ablation procedure. The prospective cohort will be followed for 12 months after initial treatment or longer if BE is not yet clear 6 months after the initial treatment.
Who may be able to join
- English speaking males or females aged 18 to 80.
- Meet one of the following:
- Individuals who have undergone ablation therapy for dysplastic Barrett's Esophagus (BE) or intramucosal adenocarcinoma and have had at least one clear pathology report with no BE since their first ablation (cross-sectional) OR
- Individuals with dysplastic Barrett's Esophagus (BE) or intramucosal adenocarcinoma who will undergo ablation therapy at UNC for the first time (prospective longitudinal)
- Able to read, comprehend, and complete the informed consent form.
Who cannot join
- Bleeding disorder or other contraindication of endoscopic biopsy.
- Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after Esophagogastroduodenoscopy (EGD)).
- History of partial or complete esophagectomy.
- Current diagnosis of invasive esophageal cancer.
- Prior ablation of the cardia.
- Patients who have received or will receive endoscopic mucosal resection (EMR) on the day of enrollment of the gastric cardia or distal esophagus, defined as the top of the gastric folds (TGF) +2 centimeters through the top of the gastric folds -1 centimeter (TGF+2 through TGF-1). Prior EMR and/or EMR on the day of enrollment of areas other than TGF+2 through TGF-1 are OK.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
We propose a tissue sample collection study for patients at UNC who have undergone or will undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal adenocarcinoma as part of routine medical care.
Purpose:
Read more
To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and after ablative therapy.
To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative therapy.
To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the cardia.
To assess the ability of immunohistochemical (IHC) staining of cardia tissues to predict incident dysplasia in the cardia. Several well-characterized biomarkers, including p16, p53, Ki67, cyclin D1, and cyclin A, will be assessed.
Read the detailed description
This study will consist of a cross-sectional arm, as well as a prospective longitudinal arm, and will include patients who are undergoing ablative therapy at UNC. The cross-sectional arm will consist of patients who have undergone ablative therapy for Barrett's Esophagus (BE) and have had at least one clear pathology report with no evidence of Barrett's Esophagus (BE) since their first ablation. Concurrently enrolled will be a prospective longitudinal arm which will consist of patients prior to their first ablation procedure. The prospective cohort will be followed for 12 months or longer if Barrett's Esophagus (BE) is not yet clear 6 months after the initial treatment.
Sampling of the gastric cardia for clinical pathology has become common in patients who are receiving or have received ablation therapy based on evidence from previous research suggesting concern for dysplasia in the gastric cardia. In each group, research biopsies will be taken at the top of the gastric folds (TGF) as well as the gastric cardia (TGF+1cm) and distal esophagus (TGF-1).
Clinical biopsies will consist of standard esophageal biopsies from the distal esophagus as well as biopsies from TGF, TGF+1cm and TGF+2 cm. Clinical biopsy specimens will be fixed and reviewed by a pathologist to determine the presence of any metaplastic, dysplastic, or neoplastic changes, as per our usual clinical practice. Research specimens will undergo immunohistochemical (IHC) staining for a number of biomarkers that have been found to be positive in patients with dysplastic BE (p16, p53, Ki67, cyclin D1, and cyclin A). 1-4 Cross-sectional participants will receive one-time study biopsies. Prospective longitudinal participants will receive biopsies prior to ablation therapy and 6 and 12 months after the initial treatment. If Barrett's Esophagus (BE) is not yet clear at 6 months, biopsies will be taken at the first endoscopy after Barrett's Esophagus (BE) clearance and again at the next clinically scheduled follow-up visit.
- Keywords
- Barrett's Esophagus, Intestinal metaplasia, Intramucosal Adenocarcinoma, Gastric Cardia, High Cardia Dysplasia, Radiofrequency ablation (RFA)
- Medical subject headings
- Barrett Esophagus
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 |
|---|---|---|
| Cross-Sectional Post-Ablation | The cross-sectional arm will consist of patients who have undergone ablative therapy for Barrett's Esophagus (BE) and have had at least one clear pathology report with no evidence of Barrett's Esophagus (BE) since their first ablation. Cross-sectional participants will receive one-time study biopsies during a routine care follow-up endoscopy. | |
| Prospective Longitudinal Pre-Ablation | Concurrently enrolled will be a prospective longitudinal arm which will consist of patients prior to their first ablation procedure. The prospective cohort will be followed for 12 months or longer if Barrett's Esophagus (BE) is not yet clear 6 months after the initial treatment. Prospective longitudinal participants will receive biopsies prior to ablation therapy and 6 and 12 months after the initial treatment. If Barrett's Esophagus (BE) is not yet clear at 6 months, biopsies will be taken at the first endoscopy after Barrett's Esophagus (BE) clearance and again at the next clinically scheduled follow-up visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of dysplasia before and after ablation
Simple proportions will be generated to describe the prevalence of cardiac dysplasia prior to endoscopic ablation. To compare the proportion of subjects demonstrating cardiac dysplasia who have had complete eradication of Barrett's Esophagus (BE) to the proportion of subjects demonstrating cardiac dysplasia who have not had complete eradication of Barrett's Esophagus (BE), due to the dichotomous nature of the variable, we will initially create 2x2 contingency tables and perform bivariate analysis using χ2, which will serve as our primary statistical analysis. Effects will be summarized as risk ratios. To analyze the operating characteristics of various biomarkers to predict cardiac dysplasia, sensitivity, specificity, positive predictive value and negative predictive value of each biomarker to predict the presence of dysplasia at 6 and 12 months will be calculated.
Measured: Enrollment and 6 and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2017
- Study completionMay 2017
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.
- More trials run by University of North Carolina, Chapel HillThe 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
- Other
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- CSA Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicholas Shaheen, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787864
- Sponsor's protocol ID
- 12-0336
- Status last verified
- May 2017
- First submitted
- 6 Feb 2013
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plans to share data
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dysplasia of the Gastric Cardia
- ClinicalTrials.gov ID
- NCT01787864
- Acronym / sponsor ID
- 12-0336
- Keywords
- Barrett's Esophagus, Intestinal metaplasia, Intramucosal Adenocarcinoma, Gastric Cardia, High Cardia Dysplasia, Radiofrequency ablation (RFA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- CSA Medical, Inc.
- Study start
- Feb 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Feb 2013 (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.
We propose a tissue sample collection study for patients at UNC who have undergone or will undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal adenocarcinoma as part of routine medical care.
Purpose:
To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and after ablative therapy.
To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative therapy.
To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the cardia.
To assess the ability of immunohistochemical (IHC) staining of cardia tissues to predict incident dysplasia in the cardia. Several well-characterized biomarkers, including p16, p53, Ki67, cyclin D1, and cyclin A, will be assessed.
Detailed description
This study will consist of a cross-sectional arm, as well as a prospective longitudinal arm, and will include patients who are undergoing ablative therapy at UNC. The cross-sectional arm will consist of patients who have undergone ablative therapy for Barrett's Esophagus (BE) and have had at least one clear pathology report with no evidence of Barrett's Esophagus (BE) since their first ablation. Concurrently enrolled will be a prospective longitudinal arm which will consist of patients prior to their first ablation procedure. The prospective cohort will be followed for 12 months or longer if Barrett's Esophagus (BE) is not yet clear 6 months after the initial treatment.
Sampling of the gastric cardia for clinical pathology has become common in patients who are receiving or have received ablation therapy based on evidence from previous research suggesting concern for dysplasia in the gastric cardia. In each group, research biopsies will be taken at the top of the gastric folds (TGF) as well as the gastric cardia (TGF+1cm) and distal esophagus (TGF-1).
Clinical biopsies will consist of standard esophageal biopsies from the distal esophagus as well as biopsies from TGF, TGF+1cm and TGF+2 cm. Clinical biopsy specimens will be fixed and reviewed by a pathologist to determine the presence of any metaplastic, dysplastic, or neoplastic changes, as per our usual clinical practice. Research specimens will undergo immunohistochemical (IHC) staining for a number of biomarkers that have been found to be positive in patients with dysplastic BE (p16, p53, Ki67, cyclin D1, and cyclin A). 1-4 Cross-sectional participants will receive one-time study biopsies. Prospective longitudinal participants will receive biopsies prior to ablation therapy and 6 and 12 months after the initial treatment. If Barrett's Esophagus (BE) is not yet clear at 6 months, biopsies will be taken at the first endoscopy after Barrett's Esophagus (BE) clearance and again at the next clinically scheduled follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional Post-Ablation | – | –The cross-sectional arm will consist of patients who have undergone ablative therapy for Barrett's Esophagus (BE) and have had at least one clear pathology report with no evidence of Barrett's Esophagus (BE) since their first ablation. Cross-sectional participants will receive one-time study biopsies during a routine care follow-up endoscopy. |
| Prospective Longitudinal Pre-Ablation | – | –Concurrently enrolled will be a prospective longitudinal arm which will consist of patients prior to their first ablation procedure. The prospective cohort will be followed for 12 months or longer if Barrett's Esophagus (BE) is not yet clear 6 months after the initial treatment. Prospective longitudinal participants will receive biopsies prior to ablation therapy and 6 and 12 months after the initial treatment. If Barrett's Esophagus (BE) is not yet clear at 6 months, biopsies will be taken at the first endoscopy after Barrett's Esophagus (BE) clearance and again at the next clinically scheduled follow-up visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of a cross-sectional arm, as well as a prospective longitudinal arm, and will include patients who are undergoing ablative therapy at UNC. The cross-sectional arm will consist of patients who have undergone ablative therapy for Barrett's Esophagus (BE) and have had at least one clear pathology report with no evidence of BE since their first ablation. Concurrently enrolled will be a prospective longitudinal arm which will consist of patients prior to their first ablation procedure. The prospective cohort will be followed for 12 months after initial treatment or longer if BE is not yet clear 6 months after the initial treatment.
Key inclusion criteria (5 listed)
- English speaking males or females aged 18 to 80.
- Meet one of the following:
- Able to read, comprehend, and complete the informed consent form.
Key exclusion criteria (7 listed)
- Bleeding disorder or other contraindication of endoscopic biopsy.
- Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after Esophagogastroduodenoscopy (EGD)).
- History of partial or complete esophagectomy.
- Current diagnosis of invasive esophageal cancer.
- Prior ablation of the cardia.
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
Presence of dysplasia before and after ablation
Time frame: Enrollment and 6 and 12 months post treatment
Simple proportions will be generated to describe the prevalence of cardiac dysplasia prior to endoscopic ablation. To compare the proportion of subjects demonstrating cardiac dysplasia who have had complete eradication of Barrett's Esophagus (BE) to the proportion of subjects demonstrating cardiac dysplasia who have not had complete eradication of Barrett's Esophagus (BE), due to the dichotomous nature of the variable, we will initially create 2x2 contingency tables and perform bivariate analysis using χ2, which will serve as our primary statistical analysis. Effects will be summarized as risk ratios. To analyze the operating characteristics of various biomarkers to predict cardiac dysplasia, sensitivity, specificity, positive predictive value and negative predictive value of each biomarker to predict the presence of dysplasia at 6 and 12 months will be calculated.
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 16 May 2017.
- Individual participant dataSharing planned: No. No plans to share data
Related trials for Barrett's Esophagus
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
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Impact of RFA on Esophageal Distensibility and Mucosal Impedance
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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.
Nicholas Shaheen, MD, MPH principal investigator
UNC Chapel Hill
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's Esophagus and Intestinal Metaplasia, run by University of North Carolina, Chapel Hill 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 5 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: finished, as of the sponsor's last update on 16 May 2017. 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?
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?
Presence of dysplasia before and after ablation (time frame: Enrollment and 6 and 12 months post treatment). 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 May 2017.