[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"childhood-brain-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:childhood-brain-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,88,115,143,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100622310","biomarkers-of-brain-injury-in-children-with-brain-tumors-100622310",false,"NCT07381959","Biomarkers of Brain Injury in Children With Brain Tumors","Biomarkörer för hjärnskada Hos Barn Med hjärntumör","BiomarkCBT","Inclusion Criteria, Group A (treated with radiation):\n\n* Age 0-17 years old, AND\n* Diagnosed with primary brain tumor through surgery, biopsy, or other diagnostic method (e.g., for germinoma) at Uppsala University Hospital or at another university hospital in Sweden, AND\n* Referred for radiotherapy at Skandion Clinic in Uppsala and\u002For at their local hospital (in some cases), with\u002Fwithout the addition of other cancer treatments.\n\nInclusion Criteria, Group B (treated without radiation\u002Fradiation naive):\n\n* Age 0-17 years old, AND\n* Diagnosed with primary brain tumor through surgery, biopsy, or other diagnostic method (e.g., for optic pathway glioma in neurofibromatosis type 1 and germinoma) at Uppsala University Hospital or at another university hospital in Sweden, AND\n* Not referred to radiotherapy and treated with\u002Fwithout the addition of other cancer treatments.\n\nInclusion Criteria, Group C (healthy control group):\n\n* Age 0-17 years old at time of recruitment\n\nExclusion Criteria, Groups A + B:\n\n* Diagnosed with a tumor only in the spinal cord (solitary spinal tumor).\n* Diagnosed with a tumor considered palliative already at diagnosis (e.g., diffuse intrinsic pontine glioma)\n\nExclusion Criteria, Group C:\n\n* Have diagnosis of chronic disease that requires continuous medication.\n\nExclusion Criteria, all groups:\n\n* Unable to provide informed consent due to language difficulties.",true,"ALL","17 Years",{"count":21,"type":22},560,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to identify biomarkers of treatment-induced brain injury in children treated for primary brain tumors. The main question it aims to answer is:\n\nCan investigators identify sensitive plasma biomarker(s) of treatment-induced brain injury in children with primary brain tumors?\n\nResearchers will compare results between different treatment modalities (surgery, chemotherapy, radiation versus radiation-naive) and a healthy age- and sex-matched control population, to identify treatment-specific biomarkers.\n\nParticipants will provide plasma samples at the following time points: before surgery, 1-2 weeks after surgery, as well as at 3-, 6-, 12-, 18-, 24-, and 36 months after surgery. Participants who receive radiation treatment will also provide plasma samples before and during treatment (approximately every 2 weeks). Where possible, plasma samples are also collected before the start of any new treatment (e.g., chemotherapy). Healthy controls will provide samples once.",[26,27,28],"Brain Tumor","Childhood Cancer","Childhood Brain Tumor",[30,31,32,33,34,35],"Radiotherapy","Cranial radiation therapy","Plasma biomarkers","Extracellular vesicles","Proteomics","Childhood brain tumor","RECRUITING","2026-01-28",{"date":39,"type":40},"2026-02-02","ACTUAL",{"date":42,"type":40},"2021-08-01",{"date":44,"type":22},"2031-12-31",{"name":46,"class":47},"Uppsala University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":18,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100532119","phase-1-optimal-precision-therapies-to-customise-care-in-childhood-and-adolescent-cancer-100532119","NCT06208657","Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer","Inclusion Criteria:\n\n1. Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard therapy exists.\n2. Age \\\u003C21 years at inclusion; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type recurrent\u002Frefractory malignancy.\n3. Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair).\n4. Patients enrolled in a Phase I cohort must have either evaluable or measurable disease.\n5. Patients enrolled in a Phase II cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for the patient's tumor type.\n6. Disease evaluations, laboratory tests, and other clinical assessments that are considered standard of care may be undertaken at the patient's local oncology treatment centre with results transferred to study site for evaluation.\n7. Performance status: Karnofsky performance status (for patients \\> 16 years of age) or Lansky play score (for patients ≤ 16 years of age) ≥ 50%.\n8. Life expectancy ≥ 6 weeks.\n9. Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer-directed therapy prior to enrolment.\n10. Adequate organ function.\n11. Able to comply with scheduled follow-up and with management of toxicity.\n12. Females of childbearing potential must have a negative serum or urine pregnancy test.\n13. Fertile males must agree to use adequate contraception during the study and following completion of treatment.\n14. Provide a signed and dated informed consent form.\n\nExclusion Criteria:\n\n1. Patients with symptomatic central nervous system (CNS) primary or metastatic tumours who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included.\n2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, or malabsorption syndrome) - only for arms that include orally administered therapeutic agents.\n3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart failure within 12 months of screening.\n4. Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.\n5. Major surgery within 21 days of the first dose of investigational drug. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumour biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before the first dose of the investigational drug is administered.\n6. Known hypersensitivity to any study drug or component of the formulation.\n7. Pregnant or nursing (lactating) females.\n8. Any other concomitant serious medical condition or organ dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the investigational drug(s).","0 Years","21 Years",{"count":58,"type":22},90,"INTERVENTIONAL",[61,62],"PHASE1","PHASE2","A companion platform trial to test novel targeted agents based on the patient's tumor profile.",[27,65,28,66,67],"Childhood Solid Tumor","Recurrent Cancer","Refractory Cancer",[69,70,71,72,73,74,75,76,77,78],"children","basket trial","platform study","pediatric","solid tumor","paediatric","solid tumour","CNS tumor","CNS tumour","lymphoma","2026-01-26",{"date":37,"type":40},{"date":82,"type":40},"2024-07-10",{"date":84,"type":22},"2035-12",{"name":86,"class":47},"Australian & New Zealand Children's Haematology\u002FOncology Group",14,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":95,"targetDuration":97,"studyType":23,"phases":4,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100241140","international-hit-med-registry-i-hit-med-100241140","NCT02417324","International HIT-MED Registry (I-HIT-MED)","International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours","Inclusion Criteria:\n\n* all patients with above mentioned diagnosis of all ages (except for ependymoma WHO I°, pineal parenchymal tumour of intermediate differentiation and papillary tumour of the pineal region, who will be registered only if primary diagnosis was before the 18th birthday)\n* any localisation of the primary tumour\n* all clinical stages\n* First diagnosis after 01.01.2012\n* No inclusion into a prospective clinical trial for the same diagnosis, due to non-eligibility, national lack of trial approval, or individual refusal of participation.\n* Written informed consent for data transfer and tumour sample submission according to the laws of each participating country is necessary.\n* National and\u002F or local ethical committee approval according to the laws of each participating country is necessary.\n\nExclusion Criteria:\n\n* Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).\n* Lack of valid ethical committee approval.",{"count":96,"type":22},500,"5 Years","The I-HIT-MED registry registers clinical of children and adults with medulloblastoma, ependymoma, pineal tumours, or choroid plexus tumours in Germany and other countries that fulfil national ethic requirements for participation in this registry. These tumours are rare diseases, and many patients are treated outside of clinical trials. The I-HIT-MED registry allows collection of data und biological material from those patients, and provides a basis for standard treatment recommendations and counselling. It aims to improve the international cooperation and the medical knowledge in these rare diseases. Within the I-HIT-MED registry, it is a goal to maintain and improve networks for quality assurance in national groups where they are already established, and to support the implementation in national groups, where there is no quality assurance network yet.",[28],[101,102,103,104],"medulloblastoma","ependymoma","pineal tumour","CPT","2025-11-27",{"date":107,"type":40},"2025-12-04",{"date":109,"type":4},"2015-01",{"date":111,"type":22},"2029-12",{"name":113,"class":47},"Universitätsklinikum Hamburg-Eppendorf",57,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":18,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":59,"phases":125,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":48},"100279183","cognitive-biomarkers-in-pediatric-brain-tumor-patients-100279183","NCT02914067","Cognitive Biomarkers in Pediatric Brain Tumor Patients","Cohort 1 (30 patients will be enrolled to this cohort)\n\nInclusion Criteria:\n\n* Between 4 and 18 years of age, inclusive\n* Newly diagnosed primary brain tumor of any location and any histology\n* Life expectancy of at least one year\n* Able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable\n\nExclusion Criteria:\n\n* Presence of visual impairment to an extent that the patient is unable to complete the computer testing\n* Contraindication to MRI scan (i.e. due to cardiac pacemaker)\n* Programmable Shunt\n\nCohort 2 (150 patients will enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1.)\n\nInclusion Criteria:\n\n* Between 4 and 18 years of age, inclusive\n* Previous diagnosis of a posterior fossa brain tumor; patients who are either undergoing active treatment for posterior fossa tumor or who have completed treatment will be eligible for study enrollment\n* Life expectancy of at least one year\n* Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable\n\nExclusion Criteria:\n\n* Presence of visual impairment to an extent that the patient is unable to complete the computer testing\n* Contraindication to MRI scan (i.e. due to cardiac pacemaker)\n\nCohort 3 (20 patients will be enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1) Inclusion Criteria\n\n* Between 4 and 18 years of age, inclusive\n* Previous diagnosis of a posterior fossa brain tumor\n* Clinical diagnosis of post-operative posterior fossa syndrome\n* Inability to complete NIH Toolbox\n* Life expectancy of at least one year\n* Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable\n\nExclusion Criteria\n\n* Contraindication to MRI scan (i.e. due to cardiac pacemaker)\n\nCohort 4 (50 Patients will be enrolled to Cohort 4. This will include patients previously enrolled on Cohorts 1-3 above.)\n\nInclusion Criteria\n\n* Between 12-30 years of age, inclusive\n* Diagnosis of a brain tumor \\>3 years prior to study enrollment\n* Life expectancy of at least one year\n* Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable\n* Patient must be able to complete a 1 hour MRI scan without sedation\n\nExclusion Criteria\n\n* Contraindiciation to MRI scan (i.e. due to cardian pacemaker)\n* Presence of dental braces or programmable shunt\n* Patient requires sedation for MRI scan","4 Years","18 Years",{"count":124,"type":22},200,[126],"NA","The investigators will focus on three cohorts of brain tumor patients aged, 4-18 years, to answer two critical questions: 1) Can the investigators acquire high quality data relevant to cognitive function during the peri-diagnostic period and, 2) can the investigators develop predictive models for cognitive outcomes using serial examination of functional imaging and cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior fossa will be eligible for cohort 2. For cohort 3, eligible patients will include patients with a clinical diagnosis of posterior fossa syndrome with physical impairments that prohibit completion of the NIH Toolbox Cognitive Battery. The investigators have decided to expand the eligible tumor types to better capture the most significant deficit variability that can be caused by tumors outside the posterior fossa. Thus, this focus will provide a platform to analyze the impact that different tumor types and different standard treatments have on cognitive dysfunction. The rationale for inclusion of subjects on cohort 3 is that posterior fossa syndrome is one of the most cognitively devastating diagnoses following a posterior fossa surgery. The causes of posterior fossa syndrome and unknown and there are currently no interventions to improve symptoms. RsfcMRI would offer a novel and non-invasive assessment of posterior fossa syndrome patients by assessing connectivity within and outside of the cerebellum. Expanding the tumor eligibility will allow us to further explore the effect tumor location will have on cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the necessary data points to establish trajectories of cognitive development and recovery in this population.",[28],[130,131,132,133],"Pediatric brain tumors","Cognitive deficits","Resting state functional connectivity","NIH toolbox","2025-11-20",{"date":136,"type":40},"2025-11-21",{"date":138,"type":40},"2016-10-26",{"date":140,"type":22},"2029-01-31",{"name":142,"class":47},"Washington University School of Medicine",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":18,"minAge":151,"maxAge":122,"enrollmentInfo":152,"targetDuration":4,"studyType":59,"phases":154,"briefSummary":155,"conditions":156,"keywords":160,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":48},"100575288","the-flame-cognitive-rehabilitation-study-for-childhood-brain-tumour-100575288","NCT06770335","The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour","Strategy-based Cognitive Rehabilitation with Integrated Fatigue Management for Patients with Paediatric Brain Tumour (PBT): an Acceptability and Feasibility Study of the Fatigue, Learning and Memory Enrichment (FLaME) Intervention","FLaME","Inclusion Criteria:\n\n1. Age range: 7 years to 17 years, 11 months.\n2. Received diagnosis and\u002For treatment\u002Fsurveillance at GOSH for a childhood tumour that involved the CNS (brain) and\u002For oncology treatment to brain.\n3. Received or receiving a neuropsychological assessment\u002Fconsultation at GOSH over the course of the study period or in the 48 months prior to the study period, or under active surveillance with the neuro-oncology multidisciplinary team during the study period.\n4. At least 6 months post-diagnosis\u002Facute treatment (surgery and\u002For radiotherapy), and 3 months post-return to school, with stable disease.\n5. One or more scores outside of normal limits (i.e. 1 SD above or below the mean in the direction indicating difficulty) in at least one neuropsychological domain (on performance-based tests or questionnaire-based rating scales).\n6. Report impairment (z-score \\> -0.67) in fatigue on one or more subscales of the PedsQL Multidimensional Fatigue Scale.\n7. Capacity\u002Fcompetence of patient or parent\u002Fcarer to provide informed\n\nExclusion Criteria:\n\n1. Completed or having another targeted formal psychological intervention for cognitive rehabilitation or fatigue in the past 6 months.\n2. Sensorimotor (e.g., visual-motor) impairment only on neuropsychological assessment without additional cognitive difficulty.\n3. Current substance misuse from self-report.\n4. Currently receiving formal psychiatric care for a diagnosed mental health disorder (including active suicidal ideation), excluding ADHD treatment (if a child has a diagnosis of ADHD they should be treated).\n5. Intellectual Disability based on a standard score of more than 2 standard deviations below the mean on a general adaptive behaviour composite and, where available, the General Ability Index of intellect.\n6. Patient and parent\u002Fcarer is unable to communicate verbally and in written form in English.","7 Years",{"count":153,"type":22},36,[126],"Medical treatments have improved survival rates for children with brain tumours. However, most children experience long-term difficulties with 'cognition' (thinking skills such as memory and paying attention) and cognitive fatigue (excessive mental tiredness) after treatment. Thinking difficulties and fatigue can affect a child's ability to learn, and their social and emotional wellbeing. National guidance recommends treatment called 'cognitive rehabilitation' which teaches skills to improve or manage cognitive difficulties. Families often request this, but it is not usually available due to little research. Fatigue may also get in the way of children using and benefiting from cognitive rehabilitation. No research study has offered a fatigue treatment for children recovering from brain tumours. The study aims to see if it is practical and helpful to families to provide cognitive rehabilitation for children affected by brain tumours. The treatment focuses on strategies to help cognition. The investigators will see if adding strategies to manage fatigue helps. The study will include thirty-six 7-17-year-olds who have been treated for brain tumour at Great Ormond Street Hospital. All participants will have had an assessment describing cognitive strengths and weaknesses as part of usual care. Participants will be randomly allocated to one of three groups: 1) cognitive rehabilitation with fatigue management (12 weeks), 2) cognitive rehabilitation only (6 weeks), or 3) usual care. Each child and their carer will complete questionnaires before, during, and after the treatment, and an interview at the end of the treatment. This information will help the researchers see if families find the treatment helpful and practical to take part in, and if adding fatigue strategies is beneficial. Researchers will look at information such as the number of appointments attended, feedback about the treatment, and information about fatigue levels, cognition, and wellbeing. The findings will be used to develop a UK-wide study.",[28,157,158,159],"Childhood Brain Tumors","Pediatric Brain Neoplasms","Pediatric Brain Tumor",[161,162,163,164,165,166,167,168,169],"Paediatric brain tumour","cognitive rehabilitation","cognition","fatigue","feasibility","acceptability","neuropsychology","neurocognitive","childhood brain tumour","NOT_YET_RECRUITING","2025-01-07",{"date":173,"type":40},"2025-01-13",{"date":175,"type":22},"2025-03-10",{"date":177,"type":22},"2026-12-31",{"name":179,"class":47},"Great Ormond Street Hospital for Children NHS Foundation Trust",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":18,"minAge":55,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100478038","precision-medicine-for-every-child-with-cancer-100478038","NCT05504772","Precision Medicine for Every Child With Cancer","ZERO2","Inclusion Criteria:\n\n1. Age \\\u003C 18 years Note: Individual patients aged 19 - 25 years old with a pediatric cancer, e.g., neuroblastoma, may be enrolled after discussion with, and at the discretion of, the Study Chair or their delegate.\n2. Life expectancy \\>6 weeks at time of enrolment\n3. Consent i. Signed and dated informed consent for study enrolment from participant aged ≥ 18 years or from parent\u002Fguardian of participant aged \\\u003C18 years. ii. Separate signed and dated informed consent for understanding the role of germline testing and choice for the return of germline results.","25 Years",{"count":189,"type":22},3500,"To improve outcomes for childhood cancer patients through the implementation of precision medicine.",[27,65,28,192,67,193],"Childhood Leukemia","Relapsed Cancer",[69,195,196,197,72,74],"precision medicine","personalised medicine","molecular profiling","2024-07-16",{"date":200,"type":40},"2024-07-17",{"date":202,"type":40},"2022-12-16",{"date":204,"type":22},"2030-07",{"name":86,"class":47},11]