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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00246 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE6214 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| U54CA163060 | U.S. NIH Grant/Contract | View source | |
| P50CA150964 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-endoscopic inflatable balloon for the esophagus | Device | Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to 1 year |
| Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays | Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amitabh Chak | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2016 | Sep 25, 2019 |
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| Questionnaire Administration | Other | Ancillary studies |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| esophagogastroduodenoscopy | Procedure | Standard of care, patients digestive tract scoped post balloon brushing |
|
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| Up to 7 months |
| Average Methylation of Zinc Finger Protein 793 Assay | Average methylation of zinc finger protein 793 assay | Up to 7 months |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who were successfully able to swallow the device | Posted | Number | number of participants | At completion of study procedure (up to 60 minutes) |
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| 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. | 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. | Posted | Number | % sensitivity | Up to 1 year |
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| 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. | 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. | Posted | Number | % specificity | Up to 1 year |
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| Primary | Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays | Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays | Data not collected | Posted | Up to 7 months |
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| 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 | Data not collected | Posted | Up to 7 months |
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| Primary | Average Methylation of Zinc Finger Protein 793 Assay | Average methylation of zinc finger protein 793 assay | Data not collected | Posted | Up to 7 months |
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at procedure (average of 24 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 3-15 minutes followed by a standard EGD. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis. Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies EGD: Standard of care, patients' digestive tract examined with EGD post balloon brushing | 0 | 156 | 0 | 156 | 0 | 156 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amitabh Chak | Case Comprehensive Cancer Center | 2168443217 | axc22@cwru.edu |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2016 | Nov 5, 2019 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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| Title | Measurements |
|---|
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| 50-59 |
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| 60-69 |
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| 70-79 |
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| 80-89 |
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| 90-99 |
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| Unknown |
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| Unknown |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Choking |
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| Gagging |
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| Overall tolerance |
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