Barrett EsophagusNCT02451124

Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus

A study testing non-endoscopic inflatable balloon for the esophagus, Questionnaire Administration and Laboratory Biomarker Analysis in people with Barrett Esophagus, run by Case Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Barrett Esophagus
What is being tested?: non-endoscopic inflatable balloon for the esophagus, Questionnaire Administration and Laboratory Biomarker Analysis
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 2 sitesUnited States
Study dates: Jul 2015to 29 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
Patients can provide informed consent
Patients have no known coagulopathy and no known history of esophageal varices

Who cannot join

Patients are not undergoing clinically indicated EGD
Patients have known coagulopathies or history of esophageal varices
Patients do not have the ability to give informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Office Based Screening Test for Barrett's Esophagus

This pilot clinical trial studies non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a condition where the lining of the esophagus has changed or been replaced with abnormal cells that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule balloon that brushes against the walls of the esophagus to collect esophageal samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.

Read the detailed description

PRIMARY OBJECTIVES:

To determine acceptability of non-endoscopic balloon brushing of esophagus.

II. To demonstrate successful performance of the methylation of vimentin (mVIM) assay in balloon brushings from subjects with and without Barrett's Esophagus (BE).

III. To examine molecular and histological factors that might lead to false negative and false positive mVIM assays in BE screening.

IV. To assay additional methylated deoxyribonucleic acid (DNA) biomarkers that might improve the sensitivity and specificity of mVIM in balloon brushings.

OUTLINE:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy (EGD).

After completion of study, patients with serious adverse events are followed up until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.

Conditions: Barrett Esophagus
Being tested: non-endoscopic inflatable balloon for the esophagus, Questionnaire Administration, Laboratory Biomarker Analysis, esophagogastroduodenoscopy
Keywords: Barrett, Cancer, Screening
Medical subject headings: Barrett Esophagus, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

non-endoscopic inflatable balloon for the esophagusDevice
Also called Balloon
Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus
Questionnaire AdministrationOther
Ancillary studies
Laboratory Biomarker AnalysisOther
Correlative studies
esophagogastroduodenoscopyProcedure or surgery
Also called EGD
Standard of care, patients digestive tract scoped post balloon brushing

Study groups in NCT02451124
Study group	Role	What they receive
Screening: non-endoscopic inflatable balloon for the esophagus	Experimental	Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis. Receives: Device: non-endoscopic inflatable balloon for the esophagus; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Procedure: esophagogastroduodenoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey
Mean tolerance score as assessed by 'tolerance survey' with scores ranging from 0 to 50 with higher scores indicating worse tolerance of interventional balloon device. Subscales include anxiety, pain, choking, gagging, and overall tolerance, with each domain scores ranging from 0 to 10, with higher scores indicating worse tolerance of interventional balloon device.
Measured: At completion of study procedure (up to 60 minutes)
Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE
Sensitivity of the mVIM assay in balloon brushings from participants with BE as measured by true positives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial diagnosis. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Measured: Up to 1 year
Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis
Specificity of the mVIM assay in balloon brushings from control subjects with BE as measured by true negatives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial control status. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Measured: Up to 1 year
Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays
Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
Measured: Up to 7 months
Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE
Performance of the mVIM assay in balloon brushings from subjects without BE
Measured: Up to 7 months
Average Methylation of Zinc Finger Protein 793 Assay
Average methylation of zinc finger protein 793 assay
Measured: Up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201529 Jan 2017

First posted21 May 2015 (estimated)
Study startJul 2015
Primary completion11 Aug 2016
Study completion29 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Barrett EsophagusStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe 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: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02451124
Sponsor's protocol ID: CASE6214
Other IDs: NCI-2015-00246, CASE6214, P30CA043703, U54CA163060, P50CA150964
Status last verified: Nov 2019
First submitted: 18 May 2015
Last updated: 6 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Barrett Esophagus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Office Based Screening Test for Barrett's Esophagus
ClinicalTrials.gov ID: NCT02451124
Acronym / sponsor ID: CASE6214
Conditions: Barrett Esophagus
Keywords: Barrett, Cancer, Screening
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jul 2015
Primary completion: 11 Aug 2016 (actual)
Study completion: 29 Jan 2017 (actual)
First posted: 21 May 2015 (estimated)
Results: Posted 6 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine acceptability of non-endoscopic balloon brushing of esophagus.

II. To demonstrate successful performance of the methylation of vimentin (mVIM) assay in balloon brushings from subjects with and without Barrett's Esophagus (BE).

III. To examine molecular and histological factors that might lead to false negative and false positive mVIM assays in BE screening.

IV. To assay additional methylated deoxyribonucleic acid (DNA) biomarkers that might improve the sensitivity and specificity of mVIM in balloon brushings.

OUTLINE:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy (EGD).

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Screening: non-endoscopic inflatable balloon for the esophagus	Experimental	Device: non-endoscopic inflatable balloon for the esophagus, Other: Questionnaire Administration, Other: Laboratory Biomarker Analysis, Procedure: esophagogastroduodenoscopyPatients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
Patients can provide informed consent
Patients have no known coagulopathy and no known history of esophageal varices

Key exclusion criteria (3 listed)

Patients are not undergoing clinically indicated EGD
Patients have known coagulopathies or history of esophageal varices
Patients do not have the ability to give informed consent

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
non-endoscopic inflatable balloon for the esophagusAlso: BalloonUndergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus	Device	Screening: non-endoscopic inflatable balloon for the esophagus
Questionnaire AdministrationAncillary studies	Other	Screening: non-endoscopic inflatable balloon for the esophagus
Laboratory Biomarker AnalysisCorrelative studies	Other	Screening: non-endoscopic inflatable balloon for the esophagus
esophagogastroduodenoscopyAlso: EGDStandard of care, patients digestive tract scoped post balloon brushing	Procedure or surgery	Screening: non-endoscopic inflatable balloon for the esophagus

Primary outcome

Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey
Time frame: At completion of study procedure (up to 60 minutes)
Mean tolerance score as assessed by 'tolerance survey' with scores ranging from 0 to 50 with higher scores indicating worse tolerance of interventional balloon device. Subscales include anxiety, pain, choking, gagging, and overall tolerance, with each domain scores ranging from 0 to 10, with higher scores indicating worse tolerance of interventional balloon device.
Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE
Time frame: Up to 1 year
Sensitivity of the mVIM assay in balloon brushings from participants with BE as measured by true positives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial diagnosis. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis
Time frame: Up to 1 year
Specificity of the mVIM assay in balloon brushings from control subjects with BE as measured by true negatives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial control status. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays
Time frame: Up to 7 months
Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE
Time frame: Up to 7 months
Performance of the mVIM assay in balloon brushings from subjects without BE
Average Methylation of Zinc Finger Protein 793 Assay
Time frame: Up to 7 months
Average methylation of zinc finger protein 793 assay

Results and safety

Results posted to the registry on 6 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Screening: Non-endoscopic Inflatable Balloon for the Esophagus	156	155

Primary outcome: Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey

Time frame: At completion of study procedure (up to 60 minutes). Number. Unit: number of participants

Measure	Low Discomfort n = 128	Intermediate Discomfort n = 128	High Discomfort n = 128
Anxiety	96	31	1
Pain	121	7	0
Choking	105	22	1
Gagging	66	58	4
Overall tolerance	92	36	0

Population analysed: Participants who were successfully able to swallow the device

Primary outcome: Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE

Time frame: Up to 1 year. Number. Unit: % sensitivity

Measure	Screening: Non-endoscopic Inflatable Balloon for the Esophagus n = 50
Value	88

Population analysed: Evaluable Cases. Cases are participants with diagnosed BE. Some cases not evaluable because of failure to swallow device, failure to obtain adequate DNA from balloon tips, or other exclusionary reasons.

Primary outcome: Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis

Time frame: Up to 1 year. Number. Unit: % specificity

Measure	Screening: Non-endoscopic Inflatable Balloon for the Esophagus n = 36
Value	92

Population analysed: Evaluable Controls. Controls were evaluable participants with with no diagnosed disease. Some controls not evaluable because of failure to swallow device, failure to obtain adequate DNA from balloon tips, or other exclusionary reasons.

Primary outcome: Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays

Time frame: Up to 7 months

Population analysed: Data not collected

Adverse events

Time frame: at procedure (average of 24 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Screening: Non-endoscopic Inflatable Balloon for the Esophagus	0 of 156 (0%)	0 of 156 (0%)	0 of 156

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Barrett 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.

Amitabh Chak principal investigator

Case Comprehensive Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 6 Nov 2019. 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?

Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey (time frame: At completion of study procedure (up to 60 minutes)). The study lists 6 primary outcomes in all. 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 NCT02451124.

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 6 Nov 2019.