[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435998":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":20,"responsibleParty":47,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":7,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":7,"enrollmentInfo":62,"targetDuration":7,"studyType":65,"phases":7,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":23,"whyStopped":7,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Viome","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"Momchilo Vuyisich, PhD","Viome Life Sciences","PRINCIPAL_INVESTIGATOR",[14,18],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","855 958 4663","studies@viome.com",{"name":19,"role":15,"phone":7,"phoneExt":7,"email":7},"Ryan Toma, MS",[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"AdventHealth Cancer Institute","RECRUITING","Orlando","Florida","32804","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-81.37924,28.53834,{"lat":33,"lon":32},[36,40,42,45],{"name":37,"role":15,"phone":38,"phoneExt":7,"email":39},"Jessica Chestnut","407 303 2451","Jessica.Chestnut@adventhealth.com",{"name":41,"role":12,"phone":7,"phoneExt":7,"email":7},"Nathalie McKenzie, MD",{"name":43,"role":44,"phone":7,"phoneExt":7,"email":7},"Robert Holloway, MD","SUB_INVESTIGATOR",{"name":46,"role":44,"phone":7,"phoneExt":7,"email":7},"James Kendrick, MD",{"type":48,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[50],{"name":51,"class":52},"AdventHealth","OTHER","100435998","gut-microbiome-and-treatment-for-gynecological-cancer-patients-receiving-immunotherapy-100435998",false,"NCT04957511","Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy","Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy","Inclusion Criteria:\n\n* Adult females \\> 18 years old\n* Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group\n* Patients for whom an immunotherapy regimen has been ordered\n\nExclusion Criteria:\n\n* Patients unable to provide fecal specimens at three time points\n* Patients unable to read or understand informed consent\n* Taking medications that may affect gut microbiome:\n\n  * Proton pump inhibitors (PPIs)\n  * Metformin\n  * Antibiotics\n  * Laxatives\n* Patients who are receiving investigational agent","FEMALE","18 Years",{"count":63,"type":64},30,"ESTIMATED","OBSERVATIONAL","30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.",[68,69,70],"Gynecologic Cancer","Immunotherapy","Gut Microbiome",[72,73,74,75,76,77,5,78,79,80,81,82,83],"Biome","Microbiome","Gastrointestinal","Immune check point inhibitors","Nutrition","Diet","ICI","ICIs","RNAseq","Anti-tumor immunity","Cancer","Gynecology","2025-01-27",{"date":86,"type":87},"2025-01-29","ACTUAL",{"date":89,"type":87},"2021-06-29",{"date":91,"type":64},"2026-06",{"name":5,"class":6},1]