[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100315102":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":56,"collaborators":58,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":10,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":162,"studyType":163,"phases":10,"briefSummary":164,"conditions":165,"keywords":185,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"fullName":5,"class":6},"Children's Hospitals and Clinics of Minnesota","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Type I PPB",null,"Type I PPB is an early manifestation of this malignant disease, cured in some cases by surgery. Surgical guidelines are presented. It is unknown whether adjuvant chemotherapy improves cure rates for individuals with Type I PPB. If the treating physicians select adjuvant chemotherapy treatment, chemotherapy options include a 22-week regimen: 4 courses of vincristine, actinomycin D and cyclophosphamide (VAC) followed by 3 courses of vincristine and actinomycin D (VA). Therapy decisions are the responsibility of the treating institution.",{"label":13,"type":10,"description":14,"interventionNames":10},"Types II and III PPB","Types II and III PPB are aggressive sarcomas. Surgery and chemotherapy are necessary in all cases. Surgical guidelines are presented. Many children with Types II or III PPB receive a single-arm multi-agent chemotherapy neo-adjuvant\u002Fadjuvant regimen of IVADo (ifosfamide, vincristine, actinomycin, doxorubicin) for 36 weeks. Second and possible 3rd look surgery may be considered for local control. Radiation therapy may be considered. Specific therapy decisions are the responsibility of the treating institution.",{"label":16,"type":10,"description":17,"interventionNames":10},"Type Ir PPB","Type Ir (regressed) PPB is a unique, purely cystic tumor which lacks a primitive cell component. The International PPB\u002FDICER1 Registry will enroll and follow participants with Type Ir PPB, regardless of age.",{"label":19,"type":10,"description":20,"interventionNames":10},"DICER1 Gene or Cond Assoc with DICER1","PPB and the associated conditions found in PPB families suggest a familial tendency to formation of tumors. The International PPB\u002FDICER1 Registry for PPB, DICER1 and Associated Conditions study will enroll and follow participants who have the DICER1 gene mutations or conditions associated with PPB or DICER1.",[22],{"name":23,"affiliation":24,"role":25},"Kris Ann P Schultz, MD","Children's Minnesota","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","612-813-7121","krisann.schultz@childrensmn.org",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Paige HR Mallinger, MS","612-813-7115","paige.mallinger@childrensmn.org",[36],{"facility":24,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Minneapolis","Minnesota","55404","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-93.26384,44.97997,{"lat":47,"lon":46},[50,51,55],{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},{"name":52,"role":28,"phone":53,"phoneExt":10,"email":54},"Anne K Harris, MPH","6128137121","anne.harris@childrensmn.org",{"name":23,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59,61,64,66,68,70,72,74,76,78,80,83,85,87,89,91,93,95,97,99,101,103,105,107,109,111,113,115,117,119,121,123,125,128,130,132,134,136,138,140,142,144,146],{"name":60,"class":6},"Washington University School of Medicine",{"name":62,"class":63},"ResourcePath, LLC","UNKNOWN",{"name":65,"class":6},"University of Cambridge",{"name":67,"class":6},"Emory University",{"name":69,"class":6},"Dana-Farber Cancer Institute",{"name":71,"class":6},"Phoenix Children's Hospital",{"name":73,"class":6},"Allina Health System",{"name":75,"class":6},"University of California, San Francisco",{"name":77,"class":6},"M.D. Anderson Cancer Center",{"name":79,"class":63},"UC Davis Children's Hospital",{"name":81,"class":82},"KK Women's and Children's Hospital","OTHER_GOV",{"name":84,"class":6},"Louisiana State University Health Sciences Center Shreveport",{"name":86,"class":6},"Children's Healthcare of Atlanta",{"name":88,"class":6},"Dayton Children's Hospital",{"name":90,"class":6},"Akron Children's Hospital",{"name":92,"class":63},"Starship Children's Hospital of New Zealand",{"name":94,"class":6},"Beijing Children's Hospital",{"name":96,"class":63},"Bronson Methodist Hospital",{"name":98,"class":6},"Rutgers Cancer Institute of New Jersey",{"name":100,"class":63},"Children's Hospital of Los Angeles (CHLA)",{"name":102,"class":6},"Children's Hospital of Philadelphia",{"name":104,"class":6},"Children's Hospital Medical Center, Cincinnati",{"name":106,"class":6},"Connecticut Children's Medical Center",{"name":108,"class":6},"Federal Scientific Clinical Centre of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogache",{"name":110,"class":6},"Driscoll Children's Hospital",{"name":112,"class":6},"Hannover Medical School",{"name":114,"class":6},"Jewish General Hospital",{"name":116,"class":6},"Kaiser Permanente",{"name":118,"class":6},"King Faisal Specialist Hospital & Research Center",{"name":120,"class":6},"Kingston Health Sciences Centre",{"name":122,"class":6},"Massachusetts General Hospital",{"name":124,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"name":126,"class":127},"National Institutes of Health (NIH)","NIH",{"name":129,"class":6},"Royal Perth Hospital",{"name":131,"class":6},"Princess Margaret Hospital for Children",{"name":133,"class":6},"Prisma Health-Upstate",{"name":135,"class":6},"Roswell Park Cancer Institute",{"name":137,"class":6},"The Hospital for Sick Children",{"name":139,"class":6},"St. Jude Children's Research Hospital",{"name":141,"class":63},"Huntsman Cancer Institute\u002F University of Utah",{"name":143,"class":6},"University of Virginia",{"name":145,"class":6},"University of Texas Southwestern Medical Center",{"name":147,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","100315102","international-ppbdicer1-registry-100315102",false,"NCT03382158","International PPB\u002FDICER1 Registry","International Pleuropulmonary Blastoma\u002FDICER1 Registry (for PPB, DICER1 and Associated Conditions)","Inclusion Criteria:\n\n1. Known or suspected PPB or related thoracic tumor\n2. Known or suspected sex-cord stromal tumor including Sertoli-Leydig cell tumor and gynandroblastoma (males or females)\n3. Other known or suspected DICER1-related condition including ovarian sarcoma, cystic nephroma, renal sarcoma, pineoblastoma, pituitary blastoma, nasal chondromesenchymal hamartoma, ciliary body medulloepithelioma and others\n4. Individuals with known or suspected DICER1 pathogenic variation regardless of whether they have an established DICER1-associated condition\n5. Informed consent by patient\u002F or parent\u002Fguardian (also, where appropriate: assent and HIPAA consent)\n\nExclusion criteria:\n\nAbsence of appropriate consent for Registry participation",true,"ALL","0 Minutes","100 Years",{"count":160,"type":161},3400,"ESTIMATED","10 Years","OBSERVATIONAL","Pleuropulmonary blastoma (PPB) is a rare malignant neoplasm of the lung presenting in early childhood. Type I PPB is a purely cystic lesion, Type II is a partially cystic, partially solid tumor, Type III is a completely solid tumor. Treatment of children with PPB is at the discretion of the treating institution. This study builds off of the 2009 study and will also seek to enroll individuals with DICER1-associated conditions, some of whom may present only with the DICER1 gene mutation, which will help the Registry understand how these tumors and conditions develop, their clinical course and the most effective treatments.",[166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184],"Pleuropulmonary Blastoma","Sertoli-Leydig Cell Tumor","DICER1 Syndrome","Cystic Nephroma","Wilms Tumor","Pineoblastoma","Renal Sarcoma","Nodular Hyperplasia of Thyroid","Nasal Chondromesenchymal Hamartoma","Ciliary Body Medulloepithelioma","Neuroblastoma","Pituitary Cancer","Embryonal Rhabdomyosarcoma","Ovarian Sarcoma","Gynandroblastoma","Thyroid Carcinoma","Embryonal Rhabdomyosarcoma of Vagina (Diagnosis)","Embryonal Rhabdomyosarcoma of Uterus (Diagnosis)","Embryonal Rhabdomyosarcoma of Cervix",[186,187,188,189,167,169,190,191,192,170,171,172,193,173,194,181,174,195,175,196,176,177,178,197,179,180,198,199,200,201,202,203,204],"pleuropulmonary blastoma","PPB","DICER1","SLCT","CN","DICER1 mutation","DICER1 syndrome","ASK","Thyroid Nodules","NCMH","CBME","ERMS","Peritoneal PPB","pPPB","multinodular goiter","PPB Type I","PPB Type II","PPB Type III","PPB Type Ir","2025-01-28",{"date":207,"type":208},"2025-01-30","ACTUAL",{"date":210,"type":208},"2016-12-06",{"date":212,"type":161},"2035-12-06",{"name":5,"class":6},1]