Nctid:
NCT00001196
Payload:
{"FullStudy"=>{"Rank"=>474431, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012859", "ConditionMeshTerm"=>"Sjogren's Syndrome"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001172", "ConditionAncestorTerm"=>"Arthritis, Rheumatoid"}, {"ConditionAncestorId"=>"D000001168", "ConditionAncestorTerm"=>"Arthritis"}, {"ConditionAncestorId"=>"D000007592", "ConditionAncestorTerm"=>"Joint Diseases"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}, {"ConditionAncestorId"=>"D000012216", "ConditionAncestorTerm"=>"Rheumatic Diseases"}, {"ConditionAncestorId"=>"D000014987", "ConditionAncestorTerm"=>"Xerostomia"}, {"ConditionAncestorId"=>"D000012466", "ConditionAncestorTerm"=>"Salivary Gland Diseases"}, {"ConditionAncestorId"=>"D000009059", "ConditionAncestorTerm"=>"Mouth Diseases"}, {"ConditionAncestorId"=>"D000009057", "ConditionAncestorTerm"=>"Stomatognathic Diseases"}, {"ConditionAncestorId"=>"D000015352", "ConditionAncestorTerm"=>"Dry Eye Syndromes"}, {"ConditionAncestorId"=>"D000007766", "ConditionAncestorTerm"=>"Lacrimal Apparatus Diseases"}, {"ConditionAncestorId"=>"D000005128", "ConditionAncestorTerm"=>"Eye Diseases"}, {"ConditionAncestorId"=>"D000003240", "ConditionAncestorTerm"=>"Connective Tissue Diseases"}, {"ConditionAncestorId"=>"D000001327", "ConditionAncestorTerm"=>"Autoimmune Diseases"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17414", "ConditionBrowseLeafName"=>"Xerostomia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15354", "ConditionBrowseLeafName"=>"Sjogren's Syndrome", "ConditionBrowseLeafAsFound"=>"Sjogren's Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4166", "ConditionBrowseLeafName"=>"Arthritis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4170", "ConditionBrowseLeafName"=>"Arthritis, Rheumatoid", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10311", "ConditionBrowseLeafName"=>"Joint Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11787", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14735", "ConditionBrowseLeafName"=>"Rheumatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6013", "ConditionBrowseLeafName"=>"Collagen Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14975", "ConditionBrowseLeafName"=>"Salivary Gland Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11709", "ConditionBrowseLeafName"=>"Mouth Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11707", "ConditionBrowseLeafName"=>"Stomatognathic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17730", "ConditionBrowseLeafName"=>"Dry Eye Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10354", "ConditionBrowseLeafName"=>"Keratoconjunctivitis Sicca", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10476", "ConditionBrowseLeafName"=>"Lacrimal Apparatus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7961", "ConditionBrowseLeafName"=>"Eye Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6154", "ConditionBrowseLeafName"=>"Connective Tissue Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4319", "ConditionBrowseLeafName"=>"Autoimmune Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9890", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Mouth and Tooth Diseases", "ConditionBrowseBranchAbbrev"=>"BC07"}, {"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"Eye Diseases", "ConditionBrowseBranchAbbrev"=>"BC11"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Prospective"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Cohort"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"1740"}}, "StatusModule"=>{"OverallStatus"=>"Terminated", "StartDateStruct"=>{"StartDate"=>"March 23, 1984"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 29, 2015", "CompletionDateStruct"=>{"CompletionDate"=>"September 29, 2015"}, "LastUpdateSubmitDate"=>"June 30, 2017", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"July 2, 2017", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"To determine the cause and severity of the subject's saivary gland dysfunction.", "PrimaryOutcomeTimeFrame"=>"1 Month"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Salivary Function", "Salivary Gland", "Sjogren's Syndrome", "Dry Mouth"]}, "ConditionList"=>{"Condition"=>["Sjogren's Syndrome", "Salivary Gland"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"3858368", "ReferenceType"=>"background", "ReferenceCitation"=>"Fox PC, van der Ven PF, Sonies BC, Weiffenbach JM, Baum BJ. Xerostomia: evaluation of a symptom with increasing significance. J Am Dent Assoc. 1985 Apr;110(4):519-25. doi: 10.14219/jada.archive.1985.0384."}, {"ReferencePMID"=>"1496162", "ReferenceType"=>"background", "ReferenceCitation"=>"Daniels TE, Fox PC. Salivary and oral components of Sjogren's syndrome. Rheum Dis Clin North Am. 1992 Aug;18(3):571-89."}, {"ReferencePMID"=>"8875029", "ReferenceType"=>"background", "ReferenceCitation"=>"Fox PC, Speight PM. Current concepts of autoimmune exocrinopathy: immunologic mechanisms in the salivary pathology of Sjogren's syndrome. Crit Rev Oral Biol Med. 1996;7(2):144-58. doi: 10.1177/10454411960070020301."}, {"ReferencePMID"=>"32939030", "ReferenceType"=>"derived", "ReferenceCitation"=>"Tanaka T, Warner BM, Odani T, Ji Y, Mo YQ, Nakamura H, Jang SI, Yin H, Michael DG, Hirata N, Suizu F, Ishigaki S, Oliveira FR, Motta ACF, Ribeiro-Silva A, Rocha EM, Atsumi T, Noguchi M, Chiorini JA. LAMP3 induces apoptosis and autoantigen release in Sjogren's syndrome patients. Sci Rep. 2020 Sep 16;10(1):15169. doi: 10.1038/s41598-020-71669-5."}, {"ReferencePMID"=>"31095438", "ReferenceType"=>"derived", "ReferenceCitation"=>"Burbelo PD, Ferre EMN, Chaturvedi A, Chiorini JA, Alevizos I, Lionakis MS, Warner BM. Profiling Autoantibodies against Salivary Proteins in Sicca Conditions. J Dent Res. 2019 Jul;98(7):772-778. doi: 10.1177/0022034519850564. Epub 2019 May 16."}, {"ReferencePMID"=>"21280008", "ReferenceType"=>"derived", "ReferenceCitation"=>"Alevizos I, Alexander S, Turner RJ, Illei GG. MicroRNA expression profiles as biomarkers of minor salivary gland inflammation and dysfunction in Sjogren's syndrome. Arthritis Rheum. 2011 Feb;63(2):535-44. doi: 10.1002/art.30131."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study will evaluate patients with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary gland secretions have antibacterial, lubricatory, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning, or ulcerated oral mucosal; problems chewing, swallowing, and speaking; and diminished taste and smell.\n\nPatients with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study. In addition, patients with recent onset of arthritis may enroll. Patients with arthritis are at risk for developing a disorder called Sjogren's syndrome, in which the glands that produce saliva may be damaged.\n\nParticipants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the jaw. Several blood samples will also be drawn for tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sjogren's syndrome and determine the extent of changes in the salivary glands. The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.", "DetailedDescription"=>"This study will evaluate participants with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary secretions have antibacterial, lubricating, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning or ulcerated or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell.\n\nParticipants with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study.\n\nParticipants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the tongue. Several blood samples will also be drawn for tests. Some participants will have a biopsy of the minor salivary glands, usually from inside the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and to determine the extent of changes in the salivary glands. An eye examination including a standard eye examination and a dry eye assessment is done. The ability to taste and smell may also be evaluated, and participants may have an ultrasound examination of their swallowing function."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"12 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nSubjects must have dry mouth symptoms (xerostomia) or a reasonable clinical suspicion of having Sj(SqrRoot)(Delta)gren s syndrome or other salivary gland disease\nAbility to provide informed consent.\n\nEXCLUSION CRITERIA:\n\na. Age less than 12 years."}, "IdentificationModule"=>{"NCTId"=>"NCT00001196", "BriefTitle"=>"Evaluation of Salivary Gland Dysfunction", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Evaluation of Salivary Gland Dysfunction", "OrgStudyIdInfo"=>{"OrgStudyId"=>"840056"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"84-D-0056"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Ilias G Alevizos, D.M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Dental and Craniofacial Research (NIDCR)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Dental and Craniofacial Research (NIDCR)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
