[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565978":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Allogeneic HCT participants",null,"The cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic.",[13,14],"Other: Vulvovaginal Symptom Questionnaire","Diagnostic Test: Vaginal Microbiome Evaluation",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"Vulvovaginal Symptom Questionnaire","Participants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant.",[9],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Vaginal Microbiome Evaluation","A vaginal microbiome evaluation will be performed via vaginal exam by a gynecologist with collection of vaginal samples once pre-transplant, six months, and twelve months post-transplant.",[9],[26],{"name":27,"affiliation":28,"role":29},"Betty K Hamilton, MD","Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","1-866-223-8100","TaussigResearch@ccf.org",[36],{"facility":28,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.69541,41.4995,{"lat":47,"lon":46},[50,53],{"name":51,"role":32,"phone":52,"phoneExt":10,"email":34},"Betty, MD","866-223-8100",{"name":27,"role":29,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":59},"Incyte Corporation","INDUSTRY","100565978","vulvovaginal-graft-versus-host-disease-diagnosis-and-microbiome-evaluation-100565978",false,"NCT06649201","Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation","Inclusion Criteria:\n\n* Female participants planning to undergo allogeneic HCT for any disease indication, OR, female participants who have already received HCT and have developed vulvovaginal GVHD during their post-transplant follow-up period\n* All conditioning regimens (myeloablative or reduced intensity) will be included.\n* All donor sources (HLA matched\u002Fmismatched related, unrelated, umbilical cord, haploidentical) will be included.\n* All graft sources (bone marrow or peripheral blood stem cells) will be included.\n* All GVHD prophylaxis regimens will be included.\n* Aged 18-70.\n* English speaking and able to sign written informed consent.\n* Participants agree to a vaginal gynecologic exam.\n* Co-enrollment on other clinical trials will be allowed.\n\nExclusion Criteria:\n\n* Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain.\n* Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments.\n* Participants with a current diagnosis of a sexually transmitted infection (STI) (Herpes Simplex Virus, Gonorrhea, Chlamydia, Trichomonas,) or a history of previously untreated STI which may incite inflammation that will impact the microbiome.\n* Participants with a history of lichen sclerosis, lichen planus, pre-transplant.\n* Participants with a history or current diagnosis of vaginal or vulvar malignancy.","FEMALE","18 Years","70 Years",{"count":70,"type":71},40,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are:\n\n* Is the vaginal microbiome altered during allogeneic HCT?\n* What changes may help researchers understand the development of vulvovaginal GVHD?\n\nParticipants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.",[75,76],"Graft Vs Host Disease","Vulvovaginal Signs and Symptoms",[78,79,80,81,82,83],"Allogeneic Hematopoietic Cell Transplantation","Vaginal Microbiome","GVHD","HCT","Vulvovaginal GVHD","Vulvovaginal graft-versus-host disease","2026-03-05",{"date":86,"type":87},"2026-03-09","ACTUAL",{"date":89,"type":87},"2024-12-19",{"date":91,"type":71},"2027-02-15",{"name":5,"class":6},1]