Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05133102
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2021-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Oral Microbiome Sampling for BE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance characteristics of a microbiome-based classifier with repeated sampling', 'timeFrame': '2 months', 'description': 'Using a classifier developed from 16S rRNA gene sequencing data, the investigators will calculate the area under the receiver operating curve (AUROC) and associated 95% confidence interval for a classifier with three repeated measures per subject.'}, {'measure': 'Intra-class correlation coefficients (ICC) by BE status', 'timeFrame': '2 months', 'description': "This will be measured to determine the degree of consistency of a microbiome-based classifier for each individual's salivary microbiome assessments (three total per subject)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Saliva', 'Sampling', 'Oral Microbiome'], 'conditions': ['Barrett Esophagus']}, 'descriptionModule': {'briefSummary': "This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.", 'detailedDescription': 'Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett\'s esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett\'s esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett\'s esophagus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Enrollment will continue until a total of 250 subjects complete all three saliva specimen collections:\n\n* 50 BE patients\n* 200 controls\n\nThe investigators anticipate that approximately 10% of subjects will not complete all three specimen collections and will be excluded from the primary outcome analyses. Thus, the investigators expect to enroll \\~275 subjects to have 250 with three saliva specimen collections. There is no cap on enrollment per study site. The anticipated duration of enrollment is 2 years (24 months).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled for an upper endoscopy or had upper endoscopy within past three years\n* Eighteen years of age or older\n* Capable of producing a saliva sample\n* Able to give informed consent\n* For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies\n\nExclusion Criteria:\n\n* History of head and neck cancer or esophageal squamous cell or gastric cancer\n* History of esophageal or gastric surgery\n* Scheduled to undergo colonoscopy on the day of initial saliva collection\n* Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection\n* For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted"}, 'identificationModule': {'nctId': 'NCT05133102', 'briefTitle': 'Longitudinal Oral Microbiome Sampling for BE', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus", 'orgStudyIdInfo': {'id': 'AAAS2622'}, 'secondaryIdInfos': [{'id': 'R01CA238433', 'link': 'https://reporter.nih.gov/quickSearch/R01CA238433', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': "Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus.", 'interventionNames': ['Other: Sample collection']}, {'label': "Barrett's Esophagus", 'description': "Patients who have undergone an endoscopy within the last three years and have histologically confirmed Barrett's esophagus. BE segment must be M\\>1cm, and has not be treated with endoscopic eradication therapy (focal mucosal resection without subsequent eradication therapy is allowed).", 'interventionNames': ['Other: Sample collection']}], 'interventions': [{'name': 'Sample collection', 'type': 'OTHER', 'description': 'Collection of saliva sample', 'armGroupLabels': ["Barrett's Esophagus", 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joel H. Rubenstein, MD', 'role': 'CONTACT', 'email': 'jhr@med.umich.edu'}, {'name': 'Amy Liu', 'role': 'CONTACT', 'email': 'Liuyalie@med.umich.edu'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julian Abrams, MD', 'role': 'CONTACT', 'email': 'ja660@cumc.columbia.edu', 'phone': '212-305-1909'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Julian Abrams, MD', 'role': 'CONTACT', 'email': 'ja660@cumc.columbia.edu', 'phone': '212-305-1909'}, {'name': 'Katharine Boyce, RN', 'role': 'CONTACT', 'email': 'kb3217@cumc.columbia.edu'}], 'overallOfficials': [{'name': 'Julian Abrams, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and Epidemiology', 'investigatorFullName': 'Julian A Abrams, MD', 'investigatorAffiliation': 'Columbia University'}}}}