Barrett Esophagus
Conditions
Keywords
Barrett, Cancer, Screening
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: I. 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.
Interventions
DEVICEnon-endoscopic inflatable balloon for the esophagus
Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus
OTHERQuestionnaire Administration
Ancillary studies
OTHERLaboratory Biomarker Analysis
Correlative studies
PROCEDUREesophagogastroduodenoscopy
Standard of care, patients digestive tract scoped post balloon brushing
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD) * Patients can provide informed consent * Patients have no known coagulopathy and no known history of esophageal varices
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | 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 | 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 | 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 | 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 | Up to 7 months | Performance of the mVIM assay in balloon brushings from subjects without BE |
| Average Methylation of Zinc Finger Protein 793 Assay | Up to 7 months | Average methylation of zinc finger protein 793 assay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Screening: Non-endoscopic Inflatable Balloon for the Esophagus 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.
non-endoscopic inflatable balloon for the esophagus: Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing | 156 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Screening: Non-endoscopic Inflatable Balloon for the Esophagus |
|---|---|
| Age, Customized 20-29 | 2 Participants |
| Age, Customized 30-39 | 4 Participants |
| Age, Customized 40-49 | 10 Participants |
| Age, Customized 50-59 | 36 Participants |
| Age, Customized 60-69 | 45 Participants |
| Age, Customized 70-79 | 39 Participants |
| Age, Customized 80-89 | 11 Participants |
| Age, Customized 90-99 | 1 Participants |
| Age, Customized Unknown | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 133 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 126 Participants |
| Region of Enrollment United States | 156 participants |
| Sex/Gender, Customized Female | 48 Participants |
| Sex/Gender, Customized Male | 107 Participants |
| Sex/Gender, Customized Unknown | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 156 |
| other Total, other adverse events | 0 / 156 |
| serious Total, serious adverse events | 0 / 156 |
Outcome results
Primary
Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays
Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
Time frame: Up to 7 months
Population: Data not collected
Primary
Average Methylation of Zinc Finger Protein 793 Assay
Average methylation of zinc finger protein 793 assay
Time frame: Up to 7 months
Population: Data not collected
Primary
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.
Time frame: At completion of study procedure (up to 60 minutes)
Population: Participants who were successfully able to swallow the device
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Anxiety | 96 number of participants |
| Low Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Gagging | 66 number of participants |
| Low Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Choking | 105 number of participants |
| Low Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Overall tolerance | 92 number of participants |
| Low Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Pain | 121 number of participants |
| Intermediate Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Choking | 22 number of participants |
| Intermediate Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Anxiety | 31 number of participants |
| Intermediate Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Pain | 7 number of participants |
| Intermediate Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Gagging | 58 number of participants |
| Intermediate Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Overall tolerance | 36 number of participants |
| High Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Overall tolerance | 0 number of participants |
| High Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Gagging | 4 number of participants |
| High Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Anxiety | 1 number of participants |
| High Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Choking | 1 number of participants |
| High Discomfort | Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | Pain | 0 number of participants |
Primary
Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE
Performance of the mVIM assay in balloon brushings from subjects without BE
Time frame: Up to 7 months
Population: Data not collected
Primary
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.
Time frame: Up to 1 year
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Discomfort | Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE | 88 % sensitivity |
Primary
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.
Time frame: Up to 1 year
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Discomfort | Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis | 92 % specificity |