Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 10:10 AM
Study NCT ID:
NCT04704128
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2021-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Pathophysiological Pathways and Therapeutic Targets in Primary Stomatodynia by Salivary Metabolomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls', 'timeFrame': 'at inclusion', 'description': 'metabolites will be measured in saliva by chromatography-mass spectrometry'}], 'secondaryOutcomes': [{'measure': 'Comparative analysis of salivary neuropeptides between cases (primary BMS) and controls', 'timeFrame': 'at inclusion', 'description': 'quantitative assessment of levels of neuropeptides (NGF, histamine, tryptase, kallicrein) will be assessed in saliva in cases and controls'}, {'measure': 'Comparative analysis of salivary hormones between cases (primary BMS) and controls', 'timeFrame': 'at inclusion', 'description': 'quantitative assessment of levels of steroid hormones (cortisol, 11-desoxycortisol, DHEA, SDHEA, progesterone, 17-hydroxyprogesterone, testosterone, androstenedione) will be assessed in saliva in cases and controls'}, {'measure': 'Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls', 'timeFrame': 'at inclusion', 'description': 'quantitative assessment of levels of cytokines (IL-2, IL-6, IL-18, TNFα) will be assessed in saliva in cases and controls'}, {'measure': 'Correlation between salivary biomarkers and pain characteristics', 'timeFrame': 'at inclusion', 'description': 'metabolites profile, salivary neuropeptides, hormones and cytokines will be compared according to the category of pain (type I-II-III, neuropathic pain score DN4\\>4)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Burning Mouth Syndrome', 'Salivary metabolomic'], 'conditions': ['Primary Burning Mouth Syndrome']}, 'descriptionModule': {'briefSummary': 'Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.', 'detailedDescription': 'Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Regarding the high predominance of this pathology among women and in order to optimize the study homogeneity, only women will be enrolled in this study.\n\nIn the control group, patients will be selected for having close characteristics with cases (pairing for age +/- 5 years and for sex).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For cases : primary Burning Mouth Syndrome, based on the IHS diagnosis criteria\n* For cases : being able to realise the salivary collection\n* For controls : no primary BMS\n* For controls : being able to realise the salivary collection\n\nExclusion Criteria for both groups:\n\n* Treatment by antibiotics in the previous month\n* New treatment in the previous two weeks\n* Active smoking\n* Active infectious or inflammatory oral disease\n* Systemic disease that could have an impact on the salivary metabolome or on the neurological system\n* Being under legal guardianship\n* Opposition to the processing of personal data'}, 'identificationModule': {'nctId': 'NCT04704128', 'acronym': 'SESAME', 'briefTitle': 'Identification of Pathophysiological Pathways and Therapeutic Targets in Primary Stomatodynia by Salivary Metabolomics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins', 'orgStudyIdInfo': {'id': 'RIPH3-RNI20-SESAME'}, 'secondaryIdInfos': [{'id': '2020-A03435-34', 'type': 'OTHER', 'domain': 'IdRCB'}, {'id': '20.12.14.65838', 'type': 'OTHER', 'domain': 'SI CNRIPH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'women with primary stomatodynia', 'interventionNames': ['Other: Salivic sample']}, {'label': 'Control group', 'description': 'women without oral disease', 'interventionNames': ['Other: Salivic sample']}], 'interventions': [{'name': 'Salivic sample', 'type': 'OTHER', 'description': 'Collection of total saliva not stimulated', 'armGroupLabels': ['Case group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Department of Dermatology, Hospital University of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Mahtab SAMIMI, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}