Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
Study NCT ID:
NCT05766150
Status:
UNKNOWN
Last Update Posted:
2023-03-13
First Post:
2023-02-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Microbioma and Oral Malignant Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between oral microbioma and (pre)malignant disease.', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Prevalence of clusters of different oral pathogens will be displayed for patients with malignant disease, premalignant disease and no oral malignancy. Taxonomic representation of statistically and biologically consistent differences between patients with malignant disease, premalignant disease and no oral malignant disease will be displayed.'}], 'secondaryOutcomes': [{'measure': 'To describe the difference in oral microbioma between young (>40 years) patients with oral SCC and older (>40 years) patients with oral squamous cell carcinoma.', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Prevalence of different oral pathogens will be displayed for patients of both age groups.'}, {'measure': 'To desribe the difference in oral microbioma and stage of disease upon presentation.', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Prevalence of different oral pathogens will be displayed for patientgroups with different tumor stages.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Cancer', 'Oral Squamous Cell Carcinoma', 'Premalignant Lesion']}, 'descriptionModule': {'briefSummary': 'This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Persons visiting oral and maxillofacial surgery department in Maastricht UMC or Radboud UMC who meet the inclusion criteria can be included.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in case of no malignant disease\n* Patients are (partially) dentate (≥20 teeth)\n* Patients who have given written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Patients with a history of radiotherapy in head and neck region\n* Patients with a history of chemotherapy, immunotherapy or immunomodulating drugs\n* Patients with a previous malginancy in head and neck region\n* Edentulous patients (with or without implants)\n* Patients with removable (partial) dentures'}, 'identificationModule': {'nctId': 'NCT05766150', 'briefTitle': 'Oral Microbioma and Oral Malignant Disease', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Ziekenhuis Maastricht'}, 'officialTitle': 'Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.', 'orgStudyIdInfo': {'id': 'METC 2019-1251'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with no oral malignant disease'}, {'label': 'Patients with oral premalignant disease'}, {'label': 'Patients with oral malignant disease'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Department of Cranio- & Maxillofacial surgery, Radboud UMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'L.A.A. Vaassen', 'role': 'CONTACT', 'email': 'lauretta.vaassen@mumc.nl', 'phone': '+31 (0)43 3872010'}, {'name': 'E.R.C. Hagens', 'role': 'CONTACT', 'email': 'eliza.hagens@mumc.nl', 'phone': '+31 (0)43 3872479'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Ziekenhuis Maastricht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Drs. L.A.A. Vaassen & Dr. E.R.C. Hagens', 'investigatorFullName': 'Eliza Hagens', 'investigatorAffiliation': 'Academisch Ziekenhuis Maastricht'}}}}