[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03610906":3,"trial-entities:NCT03610906":94,"trial-summary:NCT03610906":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":51,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":74,"locations":77,"central_contacts":87,"overall_officials":88,"references":92,"see_also_links":93},"NCT03610906","14-0426.cc","Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy","Advancing Treatment for Pediatric Craniopharyngioma: Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy","ENROLLING_BY_INVITATION","2030-12","2026-03","2026-03-23","2019-03-12","University of Colorado, Denver","OTHER",true,"New data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (CPA) may not be as effective as it could be.","Current treatment regimens for pediatric CPA are limited to surgery and radiation therapy. This pilot study seeks to identify biologically rational therapeutics for the medical treatment of adamantinomatous CPA by confirming the overexpression of specific molecules.",[19],"Craniopharyngioma, Child",[21,22,23,24],"Pilot Study","Biological Targets","CTNNB1","Tumor","OBSERVATIONAL",null,[],{"count":29,"type":30},250,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"PROCEDURE","Tumor and Blood Specimens","If available, specimen will be sampled from within the tumor, and not include portions of the tumor capsule. If the tumor includes a cyst, fluid from the cyst will be sampled if available. For each tumor specimen, a companion sample of blood that would otherwise be disposed of through usual clinical practice in the operating room will also be collected.",[37],"Pediatrics with Tumors",[39,43,45,47,49],{"measure":40,"description":41,"timeFrame":42},"Identification of Potential Therapeutic Targets","Investigators will identify potential therapeutic targets through mRNA expression.","Beginning of study to end of study, up to 1 year.",{"measure":40,"description":44,"timeFrame":42},"Investigators will identify potential therapeutic targets through microarray analysis.",{"measure":40,"description":46,"timeFrame":42},"Investigators will identify potential therapeutic targets immunohistochemistry.",{"measure":40,"description":48,"timeFrame":42},"Investigators will identify potential therapeutic targets through quantitative PCR.",{"measure":40,"description":50,"timeFrame":42},"Investigators will also perform immunostaining for beta-catenin and use DNA SNaPshot analysis to determine what parts of the tumor are responsible for observed gene signatures.",[52,56,59,63],{"measure":53,"description":54,"timeFrame":55},"Survival","The amount of time the patient survives with or without the disease.","Beginning of study up to age 21 or death, whichever comes first.",{"measure":57,"description":58,"timeFrame":55},"Progression Free Survival (PFS)","The amount of time the patient survives without advancement of disease.",{"measure":60,"description":61,"timeFrame":62},"Visual Deficit Assessment","With regard to visual deficits, investigators will compare the rates of functional blindness, unilateral blindness, and visual field deficit.","At 6 and 12 months after the specimen sample was taken.",{"measure":64,"description":65,"timeFrame":62},"Pituitary Function Assessment","With regard to pituitary function, investigators will assess patients based on the quality of life impairment that is associated with their dysfunction. Assessment will be divided among 4 groups:\n\n1. No dependence on hormone supplementation or evidence of diabetes insipidus\n2. Dependence on 1 or 2 hormone supplements without diabetes insipidus\n3. The presence of diabetes insipidus with or without the need for 2 or fewer hormone supplements\n4. Diabetes Insipidus with panhypopituitarism","ALL","30 Days","21 Years",false,{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Inclusion Criteria:\n\n1. Patients between 0-21 years of age.\n2. Patients with the diagnosis or clinical suspicion of craniopharyngioma in whom planned clinical management will include tissue sampling.\n\nExclusion Criteria:\n\n1. Patients in whom final pathology does not demonstrate adamantinomatous craniopharyngioma\n2. Patients in whom tissue specimen is not obtained\u002Favailable\n3. Patients over 21 years of age.\n4. Patients who choose not to participate",[75,76],"CHILD","ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",{"lat":85,"lon":86},39.72943,-104.83192,[],[89],{"name":90,"affiliation":13,"role":91},"Todd Hankinson, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Adamantinomatous Craniopharyngioma",[98],"CTNNB1 Gene",{"nct_id":4,"found":69,"summary":26,"prompt_version":26}]