Spots Global Cancer Trial Database for Targeted Pediatric High-Grade Glioma Therapy
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Trial Identification
Brief Title: Targeted Pediatric High-Grade Glioma Therapy
Official Title: Molecularly-Guided Phase II Umbrella Trial for Children, Adolescents, and Young Adults Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma
Study ID: NCT05839379
Interventions
Study Description
Brief Summary: The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.
Detailed Description: A novel, molecularly-guided, multi-arm phase umbrella II trial is proposed in children, adolescents, and young adults with newly diagnosed HGG, including DIPG, in which we will (1) conduct comprehensive molecular screening of tumor tissue using a multi-omic approach (WES/WGS, gene fusion panels/RNASeq, DNA methylation microarray) across international CONNECT genomics cores with rapid return of clinical results, (2) stratify patients to biologically-targeted treatment arms, based on the tumor molecular profile and histopathology, and (3) perform longitudinal evaluation of peripheral blood, cerebrospinal fluid (CSF), and/or tumor tissue as well as advanced neuro-imaging to determine genomic, immune, and radiologic biomarkers predictive of response, recurrence, resistance, and toxicity. Based on results of the above tumor molecular profiling and pathology-based confirmation of HGG diagnosis, eligible patients will be assigned to one of several biologically guided treatment arms on a phase II trial. Approximately 400-450 patients will be enrolled on the screening protocol through which biospecimens (paired tumor DNA/RNA and normal comparator samples) will undergo extensive molecular profiling to assess eligibility to any of the therapeutic subprotocols of the phase II study.
Keywords
Eligibility
Minimum Age: 12 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Duke University Health System, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Texas Children's Hospital, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
Queensland Children's Hospital, South Brisbane, Queensland, Australia
Perth Children's Hospital, Perth, Western Australia, Australia
The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada
Montreal Children's Hospital, Montréal, Quebec, Canada
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ), Heidelberg, Baden-Württemberg, Germany
Princess Máxima Center, Utrecht, , Netherlands
Great Ormond Street Hospital, London, , United Kingdom
Contact Details
Name: Maryam Fouladi, MD
Affiliation: Nationwide Children's Hospital
Role: STUDY_CHAIR
Name: Margot Lazow, MD
Affiliation: Nationwide Children's Hospital
Role: STUDY_DIRECTOR
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