Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-17 @ 1:35 PM
Study NCT ID:
NCT03375060
Status:
COMPLETED
Last Update Posted:
2017-12-15
First Post:
2017-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histology Post-Endoscopic Eradication Therapy (EET)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)', 'timeFrame': '1 year', 'description': 'A composite histologic score made up of the following criteria:\n\n* Eosinophil infiltration (0: none, 1: scattered or focal, 2: diffuse or multifocal)\n* Dilated intercellular spaces (0: none, 0.5: intercellular spaces seen at 40x focal, 1: intercellular spaces seen at 40x diffuse, 1.5: intercellular spaces seen at 10x focal, 2: intercellular spaces seen at 10x diffuse)\n* Parakaratosis (0: absent, 2: present)\n* Ballooning degeneration (0: none, 1: focal, 2: extensive)\n* Basal cell hyperplasia (0: \\<15% of total thickness, 1: 15-33% of total thickness, 1.5: 33-66% of total thickness, 2: \\>66% of total thickness)\n* Columnar differentiation (0: no columnar mucosa present, 2: columnar mucosa adjacent to squamous)\n* Ulceration/erosion (0: absent, 1: present)\n\nTotal possible score: 13'}], 'secondaryOutcomes': [{'measure': '24hr pH-impedance testing: percent acid reflux', 'timeFrame': '1 year', 'description': 'Percent acid reflux'}, {'measure': '24hr pH-impedance testing: baseline impedance', 'timeFrame': '1 year', 'description': 'Baseline impedance'}, {'measure': '24hr pH-impedance testing: Demeester score', 'timeFrame': '1 year', 'description': 'Demeester score'}, {'measure': 'Correlation between histologic features and persistent reflux', 'timeFrame': '1 year', 'description': 'If participants with abnormal 24hr pH-impedance testing, as determined by outcomes 2, 3, and 4, have greater mean scores for histologic criteria evaluated in outcome 1.'}, {'measure': "Recurrence rate of intestinal metaplasia (Barrett's esophagus)", 'timeFrame': '1 year', 'description': 'Recurrence rate of intestinal metaplasia in the overall cohort and the cohort with abnormal 24hr pH-impedance testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Reflux', 'Barrett Esophagus']}, 'descriptionModule': {'briefSummary': "This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who have undergone EET and 24hr pH impedance testing as part of standard of care at Northwestern Memorial Hospital between 1/1/2009 and 12/31/2014 and who have enrolled in the Prospective Evaluation of Barrett's Esophagus database (NCT02634645).", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\- Patients who have undergone endoscopic eradication therapy and 24hr pH impedance testing as part of standard of care between 2009 and 2014.\n* \\- Individuals who have signed a consent to be part of the Prospective Evaluation of Barrett's Esophagus Study population.\n\nExclusion Criteria:\n\n* \\- Individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from the study.\n* \\- Patient who were previously unable or unwilling to give consent to the Prospective Evaluation of Barrett's Esophagus Study will be excluded."}, 'identificationModule': {'nctId': 'NCT03375060', 'briefTitle': 'Histology Post-Endoscopic Eradication Therapy (EET)', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': "Optimizing Patient Outcomes Through Early Detection of Uncontrolled Acid Reflux After Endoscopic Therapy in Barrett's Esophagus", 'orgStudyIdInfo': {'id': 'STU00205592'}}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}