Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-07 @ 12:08 AM
Study NCT ID:
NCT03216135
Status:
UNKNOWN
Last Update Posted:
2017-07-13
First Post:
2017-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], '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'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue of the esophagus. Bacterial genomic DNA to be extracted from tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2017-07-10', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial community profiling', 'timeFrame': '9 months', 'description': '16S Ribosomal RNA (rRNA)gene sequencing'}], 'secondaryOutcomes': [{'measure': 'Generate a tissue microarray', 'timeFrame': '9 months', 'description': 'After retrieval of blocks, an experienced pathologist will mark the relevant tissue areas to process into microarray'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome'], 'conditions': ['Barrett Esophagus', 'Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.', 'detailedDescription': "Gastroesophageal reflux disease, GERD, can lead to a change of the esophagus lining to a protective cell type, termed Barrett's esophagus (BE). A diagnosis of BE greatly increases the risk of developing esophageal adenocarcinoma (EAC). The incidence of EAC has been rapidly rising in the last 30 years, and the cancer has a high mortality rate. Understanding the involvement of the esophageal microbiota could lead to prevention strategies to this increasing health concern.\n\nThis study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 10 samples of 3 specific tissue types (specified as the 3 groups) will be collected as well as control samples. The number of patients enrolled may vary due to the variance of tissue type per patient. Patients will be informed that the number of patients enrolled will depend on the number of tissues needed for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or females \\>18 years of age with known or suspected GERD, Barrett's Esophagus and or esophageal adenocarcinoma or from patients who have a history of either condition.\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT03216135', 'briefTitle': "Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma", 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': "Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma", 'orgStudyIdInfo': {'id': '2017113'}}, 'armsInterventionsModule': {'armGroups': [{'label': "(GERD) with no Barrett's Esophagus", 'description': 'Squamous epithelium from patient with gastroesophageal reflux disease (GERD) with no BE or EAC diagnosed will be collected and a control sample (area with no disease).'}, {'label': "Barrett's Esophagus", 'description': 'BE/columnar epithelium from patient diagnosed with BE and a control sample (area with no disease).'}, {'label': 'Cancer Tissue', 'description': 'Cancer tissue, and a control squamous epithelium from the same patient.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70065', 'city': 'Kenner', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cris Molina', 'role': 'CONTACT', 'email': 'cris.molina@ochsner.org', 'phone': '504-464-8314'}, {'name': 'April Wendt, RN', 'role': 'CONTACT', 'email': 'awendt@ochsner.org', 'phone': '504-464-8499'}], 'facility': 'Ochsner Health System', 'geoPoint': {'lat': 29.99409, 'lon': -90.24174}}], 'centralContacts': [{'name': 'Virendra Joshi, MD', 'role': 'CONTACT', 'email': 'vjoshi@ochsner.org', 'phone': '504-842-7690'}, {'name': 'April Wendt', 'role': 'CONTACT', 'email': 'awendt@ochsner.org'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Queensland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Virendra Joshi', 'investigatorAffiliation': 'Ochsner Health System'}}}}