Barrett's EsophagusNCT00513331
Barrett's Esophagus & Gastroesophageal Reflux Disease
An observational study of Barrett's Esophagus and GERD, run by Valley Health System at 1 site in United States.
Trial summary
This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It aims to look at the long term efficacy of evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection and surveillance endoscopy with biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, GERD
- What is being tested?
- Endoscopy, Radiofrequency ablation protocol and Endoscopic mucosal resection protocol
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Referred Patients with underlying disease of BE or GERD
Who may be able to join
- Male or female, age 18 to 85.
- Patient must have Barrett's Esophagus. Patients may be enrolled based on previous endoscopy reports and/or pathology reports. It is not necessary that each patient have endoscopy for the sole purpose of enrollment.
- Must agree to allow their clinical information to be collected, stored, analyzed and reported.
- Must allow portions of their biopsy/surgical specimens to be collected, stored, analyzed and reported.
- Must agree to fill out patient questionnaires in conjunction with the research study assistant assigned to this protocol (either in person or via telephone contact) at designated timepoints.
Who cannot join
- Intestinal metaplasia of the cardia, without an esophageal columnar lining.
- Unable to provide informed consent.
- Unable or unwilling to undergo endoscopic procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Valley Health System - The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
About this study
Official title: The Valley Hospital Center for Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD)
This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It aims to look at the long term efficacy of evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection and surveillance endoscopy with biopsy. Additionally, biological analyses will be performed in hopes of identifying biomarkers associated with the progression of BE to esophageal cancer.
Read the detailed description
Barrett's esophagus (BE) is a known premalignant condition of the esophagus, predisposing to the development of esophageal adenocarcinoma. BE represents a change in the lining (mucosa) of the esophagus which is known to be produced as a result of chronic gastroesophageal reflux. The current standard of care for patients with BE includes serial performance of upper endoscopy with multiple biopsies, performed at designated time intervals. However, the emergence of new technologies for the management of this condition has made the care of these patients non-uniform, and subject to biases of individual treating physicians.
The protocol at The Valley Hospital and Blumenthal Cancer Center aims to standardize the management of patients with Barrett's esophagus, with and without dysplasia, using evidence-based, cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection, and surveillance endoscopy with biopsies. If biopsies suggest the development of carcinoma or high grade dysplasia surgical removal of the esophagus is recommended. This study aims to look at the long-term efficacy of these procedures. In addition, data regarding clinical outcomes will be collected as well as blood, tissue and surgical specimens for proteomic analysis in hopes of identifying biomarkers associated with the progression of dysplasia to adenocarcinoma. Although patients will ultimately make their own informed decisions regarding the management of their BE, this protocol serves to unify physician recommendations, and allows for the collection and interpretation of data.
- Conditions
- Barrett's Esophagus, GERD
- Being tested
- Endoscopy, Radiofrequency ablation protocol, Endoscopic mucosal resection protocol
- Keywords
- Barrett's Esophagus, GERD, Carcinoma
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
Radiofrequency ablation protocolProcedure or surgery
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
Endoscopic mucosal resection protocolProcedure or surgery
Excision of lesion using DUETTE, marketed by Wilson-Cook
| Study group | Role | What they receive |
|---|---|---|
| Algorithm #1 | Patients without visable lesions Receives: Procedure: Endoscopy | |
| Algorithm #2 | Patients with a visable lesion that is less than 1cm Receives: Procedure: Endoscopy; Procedure: Radiofrequency ablation protocol; Procedure: Endoscopic mucosal resection protocol | |
| Algorithm #3 | Patients with a visable lesion greater than 1cm Receives: Procedure: Endoscopy; Procedure: Radiofrequency ablation protocol; Procedure: Endoscopic mucosal resection protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To standardize physician recommendations and provide cutting edge technology to patients with BE and GERD, and establish a Valley Hospital Center for Barrett's Esophagus and GERD
Measured: Until study complete
Secondary outcomes (3)
To collect and store patient data regarding their Barrett's esophagus
Measured: Througout Study
To collect tissue specimens (biopsy and surgical specimens) for use in proteomic analysis to investigate the dysplasia/carcinoma sequence at the protein expression level.
Measured: throughout Study
To assess clinical outcomes of patients enrolled in The Valley Hospital Center for Barrett's Esophagus and GERD, and modify algorithms as appropriate.
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2013
- Study completionDec 2013
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.
- 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
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J. Korst, MD, Principal investigator, Valley Health Systems/ The Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513331
- Sponsor's protocol ID
- VHS07.0017
- Status last verified
- Dec 2013
- First submitted
- 6 Aug 2007
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Valley Hospital Center for Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00513331
- Acronym / sponsor ID
- VHS07.0017
- Conditions
- Barrett's Esophagus, GERD
- Keywords
- Barrett's Esophagus, GERD, Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Valley Health SystemUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Aug 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.
This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It aims to look at the long term efficacy of evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection and surveillance endoscopy with biopsy. Additionally, biological analyses will be performed in hopes of identifying biomarkers associated with the progression of BE to esophageal cancer.
Detailed description
Barrett's esophagus (BE) is a known premalignant condition of the esophagus, predisposing to the development of esophageal adenocarcinoma. BE represents a change in the lining (mucosa) of the esophagus which is known to be produced as a result of chronic gastroesophageal reflux. The current standard of care for patients with BE includes serial performance of upper endoscopy with multiple biopsies, performed at designated time intervals. However, the emergence of new technologies for the management of this condition has made the care of these patients non-uniform, and subject to biases of individual treating physicians.
The protocol at The Valley Hospital and Blumenthal Cancer Center aims to standardize the management of patients with Barrett's esophagus, with and without dysplasia, using evidence-based, cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection, and surveillance endoscopy with biopsies. If biopsies suggest the development of carcinoma or high grade dysplasia surgical removal of the esophagus is recommended. This study aims to look at the long-term efficacy of these procedures. In addition, data regarding clinical outcomes will be collected as well as blood, tissue and surgical specimens for proteomic analysis in hopes of identifying biomarkers associated with the progression of dysplasia to adenocarcinoma. Although patients will ultimately make their own informed decisions regarding the management of their BE, this protocol serves to unify physician recommendations, and allows for the collection and interpretation of data.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Algorithm #1 | – | Procedure: EndoscopyPatients without visable lesions |
| Algorithm #2 | – | Procedure: Endoscopy, Procedure: Radiofrequency ablation protocol, Procedure: Endoscopic mucosal resection protocolPatients with a visable lesion that is less than 1cm |
| Algorithm #3 | – | Procedure: Endoscopy, Procedure: Radiofrequency ablation protocol, Procedure: Endoscopic mucosal resection protocolPatients with a visable lesion greater than 1cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Referred Patients with underlying disease of BE or GERD
Key inclusion criteria (5 listed)
- Male or female, age 18 to 85.
- Patient must have Barrett's Esophagus. Patients may be enrolled based on previous endoscopy reports and/or pathology reports. It is not necessary that each patient have endoscopy for the sole purpose of enrollment.
- Must agree to allow their clinical information to be collected, stored, analyzed and reported.
- Must allow portions of their biopsy/surgical specimens to be collected, stored, analyzed and reported.
- Must agree to fill out patient questionnaires in conjunction with the research study assistant assigned to this protocol (either in person or via telephone contact) at designated timepoints.
Key exclusion criteria (3 listed)
- Intestinal metaplasia of the cardia, without an esophageal columnar lining.
- Unable to provide informed consent.
- Unable or unwilling to undergo endoscopic procedures.
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 |
|---|---|---|
| EndoscopyInitial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments. | Procedure or surgery | Algorithm #1, Algorithm #2, Algorithm #3 |
| Radiofrequency ablation protocolAblation using the HALO 360 system according to protocol established by BARRX, Inc. | Procedure or surgery | Algorithm #2, Algorithm #3 |
| Endoscopic mucosal resection protocolExcision of lesion using DUETTE, marketed by Wilson-Cook | Procedure or surgery | Algorithm #2, Algorithm #3 |
Primary outcome
To standardize physician recommendations and provide cutting edge technology to patients with BE and GERD, and establish a Valley Hospital Center for Barrett's Esophagus and GERD
Time frame: Until study complete
3 secondary outcomes
To collect and store patient data regarding their Barrett's esophagus
Time frame: Througout Study
To collect tissue specimens (biopsy and surgical specimens) for use in proteomic analysis to investigate the dysplasia/carcinoma sequence at the protein expression level.
Time frame: throughout Study
To assess clinical outcomes of patients enrolled in The Valley Hospital Center for Barrett's Esophagus and GERD, and modify algorithms as appropriate.
Time frame: Annually
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 1 Jan 2014.
Related trials for Barrett's Esophagus
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
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.
Robert J. Korst, MD principal investigator
Valley Health Systems/ The Valley Hospital
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 GERD, run by Valley Health System 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 3 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 1 Jan 2014. 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?
To standardize physician recommendations and provide cutting edge technology to patients with BE and GERD, and establish a Valley Hospital Center for Barrett's Esophagus and GERD (time frame: Until study complete). 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 1 Jan 2014.