[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503589":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":10,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,15,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Squamous Cell Carcinoma Saliva Sample Group",null,"Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at\n\n-80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.",[13,14],"Diagnostic Test: Metagenomic sequencing","Diagnostic Test: Metabolic analysis",{"label":16,"type":10,"description":11,"interventionNames":17},"Non Oral Squamous Cell Carcinoma Saliva Sample Group",[13,14],{"label":19,"type":10,"description":20,"interventionNames":21},"Oral Squamous Cell Carcinoma Stool Sample Group","Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).",[13,14],{"label":23,"type":10,"description":20,"interventionNames":24},"Non Oral Squamous Cell Carcinoma Stool Sample Group",[13,14],[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DIAGNOSTIC_TEST","Metagenomic sequencing","Shotgun metagenomic sequencing will characterize cancer-associated changes in microbial functional capacity and species\u002Fstrain-level taxonomic profiles. Metagenomics will provide data on microbial functional capacity along with broader taxonomic classifications.",[16,23,9,19],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Metabolic analysis","Metabolic analysis will be conducted using LC\u002FMS-based metabolic analysis. A targeted approach will quantify a panel of 30 compounds including Trp pathway products while a non-targeted approach, when applied to both lipid and aqueous phase compounds, will profile relative changes in compounds that may influence host",[16,23,9,19],[36],{"name":37,"affiliation":5,"role":38},"Shi-Long E Lu, MD, PhD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Yosr Doghri","CONTACT","(303) 724-6550","yosr.doghri@cuanschutz.edu",{"name":46,"role":42,"phone":47,"phoneExt":10,"email":48},"Kristi Engle Folchert","(303) 724-9528","kristi.englefolchert@cuanschutz.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University of Colorado Cancer Center","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-104.83192,39.72943,{"lat":62,"lon":61},[65,66],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},{"name":67,"role":38,"phone":10,"phoneExt":10,"email":10},"Shi-Long Lu, MD, PhD",{"type":69,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[71],{"name":72,"class":73},"National Cancer Institute (NCI)","NIH","100503589","microbiome-in-head-and-neck-squamous-cell-carcinoma-100503589",false,"NCT05837221","Microbiome in Head and Neck Squamous Cell Carcinoma","Role of Human Microbiome in Head and Neck Cancer","Inclusion Criteria:\n\n1. Subjects equal to or above the age of 18.\n2. Patients who are seen and evaluated by a provider within the adult Otolaryngology clinic at the University of Colorado Health.\n3. Patients that present with a diagnosis of OSCC.\n4. An equal number of age-matched patients who are visiting the clinic for reasons other than OSCC diagnoses, as the control group.\n5. Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Subjects under the age of 18 or over the age of 100\n2. Subjects unwilling to particiapte","ALL","18 Years","100 Years",{"count":85,"type":86},60,"ESTIMATED","OBSERVATIONAL","This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.",[90,91,92,93],"Head and Neck Cancer","Lip Cancer","Oral Cancer","Pharynx Cancer","2026-02-20",{"date":96,"type":97},"2026-02-24","ACTUAL",{"date":99,"type":97},"2025-05-23",{"date":101,"type":86},"2028-10",{"name":5,"class":6},1]