[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvar-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvar-diseases":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,85,105,151,216],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100639817","large-algorithm-setting-and-validation-study-100639817",false,"NCT07607470","Large Algorithm Setting and Validation Study","A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing","LAVA","Inclusion Criteria:\n\nBiologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:\n\n* Abnormal vaginal discharge\n* Vaginal or vulvar itching, burning, or irritation\n* Painful or uncomfortable intercourse\n* Vaginal odor\n* Painful or frequent urination\n\nExclusion Criteria:\n\n* Participants who do not meet the above-described inclusion criteria will be excluded from the study.\n* Previously enrolled in this study\n* Contraindication to vaginal swab sampling","FEMALE","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.\n\nThe Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.",[25,26,27,28,29,30,31,32,33,34,35,36,37],"Bacterial Infections","Bacterial Infections and Mycoses","Infections","Vaginitis","Vaginal Diseases","Genital Diseases, Female","Female Urogenital Diseases","Urogenital Disease","Candidiasis","Mycoses","Vulvovaginitis","Vulvar Diseases","Vaginosis, Bacterial","NOT_YET_RECRUITING","2026-05-20",{"date":41,"type":42},"2026-05-26","ACTUAL",{"date":39,"type":21},{"date":45,"type":21},"2027-01",{"name":47,"class":48},"Nanopath, Inc","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100554166","danish-vulva-cancer-recurrence-study-100554166","NCT06495554","Danish Vulva Cancer Recurrence Study","The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer","DaVulvaRec","Inclusion Criteria:\n\n* Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva\n* ≥ 18 years of age\n* Able to understand oral and written information in Danish\n\nExclusion Criteria:\n\n* Active treatment for concurrent cancer and\u002For dissemination of concurrent cancer",{"count":59,"type":21},1295,"INTERVENTIONAL",[62],"NA","The overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (VC) to identify optimal treatment- and surveillance programs.\n\nDaVulvaRec is a Danish nationwide multicenter study with patient inclusion from Aarhus University Hospital and Rigshospitalet, Denmark. Applying a mixed method research design, the investigators will collect and analyze patient-reported outcome measures in combination with procedural data to evaluate symptomatology and map actions taken during the patient's pathway from primary disease to recurrence. Furthermore, the investigators aim to examine if circulating tumor-DNA (ctDNA) can be detected in liquid biopsies from VC patients. All patients will be followed for two years or until recurrence. Patient-reported outcome measures will be completed every four months during surveillance, and liquid biopsies will be collected prospectively for later analyses.\n\nTotal number of patients to be included is 295 according to a power calculation. All patients in the clinical study will be included in the intervention group, while data on a historical control group will be obtained from The Danish Gynecological Cancer Database. Hence, the control group will consist of 1000 VC patients diagnosed between 2011-2022.\n\nHypotheses:\n\n* All patients with VC will have specific tumor markers in the primary tumor that will be detectable in liquid biopsies as ctDNA at the time of diagnosis.\n* Measurement of ctDNA after primary treatment and during surveillance will allow detection of residual disease, improve allocation for adjuvant treatment, and will allow early detection of recurrent VC.\n* Proactive use of repeated PROM assessments in combination with procedural actions during surveillance will allow early detection of recurrent VC and early identification of late effects after treatment.",[65,66,67,68,69,36,70,71,72],"Vulva Cancer","Vulva Neoplasm","Vulvar Cancer","Vulva Disease","Vulvar Neoplasms","PROM","Circulating Tumor DNA","Survivorship","RECRUITING","2026-04-28",{"date":76,"type":42},"2026-04-29",{"date":78,"type":42},"2024-08-15",{"date":80,"type":21},"2030-12-31",{"name":82,"class":83},"University of Aarhus","OTHER",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":60,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100521504","prospective-evaluation-of-infectious-vulvovaginitis-on-wound-complication-rates-after-vulvar-excision-for-premalignant-lesions-100521504","NCT06070454","Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions","Inclusion Criteria:\n\n* Must be 18 years of age\n* Has histologically confirmed non-malignant vulvar pathology\n* Is scheduled or planning for WLE\u002FSPV\n* Signed informed consent obtained prior to any protocol specific procedures\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Women who are pregnant or nursing (lactating) women at time of consent\n* No prior RT\n* No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)\n* No history of prior malignancy within the last 3 years that required systemic chemotherapy or radiation\n* Not immunosuppressed or compromised\n* No active HIV (must have undetectable viral load)\n* Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed\n* No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease\n* Uncontrolled diabetes mellitus",{"count":92,"type":21},91,[62],"Primary:\n\n* To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision\n* To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV\u002FWLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.",[28,36],"2025-10-16",{"date":98,"type":42},"2025-10-20",{"date":100,"type":42},"2024-04-25",{"date":102,"type":21},"2026-08-01",{"name":104,"class":83},"University of Virginia",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":60,"phases":115,"briefSummary":117,"conditions":118,"keywords":131,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100521874","phase-2-phase-ii-study-of-artesunate-ointment-for-the-treatment-of-vulvar-high-grade-squamous-intraepithelial-lesions-vulvar-hsil-vin23-100521874","NCT06075264","Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2\u002F3)","A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)","ART-VIN IIB","Inclusion Criteria:\n\n* Adult women age ≥ 18 years\n* Capable of informed consent\n* Able to collaborate with planned follow-up (transportation, compliance history, etc)\n* Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2\u002F3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.\n* Positive HPV test at study entry (any genotype).\n* Women of childbearing potential agree to use birth control during the dosing phase (through week 8).\n* Laboratory values at Screening of:\n\n  * Serum alanine transaminase (SGPT\u002FALT) \\\u003C 5 x upper limit of normal (ULN)\n  * Serum aspartate transaminase (SGOT\u002FAST) \\\u003C 5 x ULN\n  * Serum Bilirubin (total) \\\u003C 2.5 x ULN\n  * Serum Creatinine ≤ 1.5 x ULN\n* Weight ≥ 50kg\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Concurrent anal, vulvar, or cervical cancer\n* HIV-positive participants with a CD4 count \\\u003C 200\n* Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.\n* Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry.\n* Currently receiving systemic chemotherapy or radiation therapy for another cancer.\n* Concomitant use of Efavirenz for HIV antiretroviral treatment\n* Concomitant use of strong UGT inhibitors\n* Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study\n* Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy).\n* Concurrent treatment with systemic corticosteroids",{"count":114,"type":21},27,[116],"PHASE2","This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2\u002F3).",[36,119,120,121,122,123,124,125,126,127,128,129,130],"HPV Infection","Vulvar HSIL","Pre-Cancerous Dysplasia","HPV Disease","VIN, Usual Type","VIN 2 of Usual Type","VIN 3 of Usual Type","Vin II","Vin III","VIN Grade 2","VIN Grade 3","High Grade Intraepithelial Neoplasia",[132,133,134,135,136,137,138,139,140],"topical treatment","ointment","non-surgical","vulvar cancer prevention","high-risk HPV","human papillomavirus","HPV","vulvar HSIL","High grade lesions","2025-08-13",{"date":143,"type":42},"2025-08-14",{"date":145,"type":42},"2023-12-06",{"date":147,"type":21},"2027-12",{"name":149,"class":48},"Frantz Viral Therapeutics, LLC",5,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":159,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":60,"phases":162,"briefSummary":164,"conditions":165,"keywords":176,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100484789","phase-1-a-study-of-a-selective-t-cell-receptor-tcr-targeting-bifunctional-antibody-fusion-molecule-star0602-in-participants-with-advanced-solid-tumors-100484789","NCT05592626","A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","START-001","Inclusion Criteria:\n\n1. Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases.\n2. For Phase 1, participants must have one of the following solid tumors:\n\n   1. High mutational burden (TMB-H)\n   2. Microsatellite Instability (MSI-H)\u002FDNA mismatch repair (dMMR)\n   3. Virally associated tumors\n3. For Phase 2, participants must have one of the following solid tumors:\n\n   1. TMB-H\n   2. MSI-H\u002FdMMR\n   3. CRC (both Ras wild type and mutant)\n   4. Virally associated tumors\n   5. Metastatic triple negative breast cancer\n   6. Platinum-resistant epithelial ovarian cancer\n   7. Metastatic castration-resistance prostate cancer\n   8. Primary stage IV or recurrent non-small cell lung cancer\n   9. Immunogenic solid tumors\n\n   (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)\n4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\n   * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent);\n   * No concurrent leptomeningeal disease or cord compression.\n\nExclusion Criteria:\n\n1. Participants with a history of known autoimmune disease with exceptions of:\n\n   * Vitiligo;\n   * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;\n   * History of Graves' disease, now euthyroid for \\> 4 weeks;\n   * Hypothyroidism managed by thyroid replacement;\n   * Alopecia;\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.\n   * Adrenal insufficiency well controlled on replacement therapy.\n2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.\n3. Unhealed wounds from surgery or injury.\n4. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n5. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.\n7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.","ALL",{"count":161,"type":21},365,[163,116],"PHASE1","This is an open label, multicenter, phase 1\u002F2 study to assess the safety\u002Ftolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.",[166,167,168,169,170,171,172,173,174,69,36,175],"Advanced Solid Tumors","Genital Neoplasm, Female","Urogenital Neoplasms","Lung Neoplasm","Neoplasms by Site","Papillomavirus Infection","Epstein-Barr Virus Infections","Carcinoma","Neoplasms","Abdominal Neoplasm",[166,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205],"STAR0602","Intravenous","Antineoplastic Agents","T Cell Receptor-targeting","Bifunctional Antibody-Fusion","Specific T Cell Activator","Tumor Mutational Burden (TMB) High","Microsatellite Instability (MSI) High","Virally Associated Malignancies","Checkpoint Inhibitor Resistance","Immunotherapy","Immune Checkpoint Inhibitor Resistance","Head and Neck Cancer","Nasopharyngeal Cancer","Non-small Cell Lung Cancer","Small Cell Lung Cancer","Biliary Cancer","Melanoma","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Skin Basal Cell Carcinoma","Endometrial Cancer","Colorectal Cancer","Small Bowel Cancer","Cervical Cancer","Gastrointestinal Neoplasms","Gastric Cancer","Esophageal Cancer","Bladder Cancer","2025-07-07",{"date":208,"type":42},"2025-07-09",{"date":210,"type":42},"2023-01-04",{"date":212,"type":21},"2026-10",{"name":214,"class":48},"Marengo Therapeutics, Inc.",32,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":227,"studyType":22,"phases":4,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":49},"100507646","vulvar-disease-in-nigeria-observational-study-100507646","NCT05890092","Vulvar Disease in Nigeria Observational Study","Vulvar Disease in Nigeria - Registry ( Observationsl Study)","VdiN","Inclusion Criteria:\n\n* biological females - afab\n\nExclusion Criteria:\n\n* none-afab","10 Years","90 Years",{"count":20,"type":21},"12 Months","Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria",[36,230,231],"Vulvar Atrophy","Dermatoses","2023-05-25",{"date":234,"type":42},"2023-06-06",{"date":236,"type":42},"2023-05-03",{"date":238,"type":21},"2026-11-30",{"name":240,"class":48},"KDRS ltd"]