Health Condition 1: C719- Malignant neoplasm of brain, unspecified Health Condition 2: C729- Malignant neoplasm of central nervous system, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
University of CaliforniaSan Francisco
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants must have a pathologic diagnosis of ATRT. The diagnosis must be supported by (1) immunohistochemistry demonstrating loss of INI1 or BRG1 or (2) identification of a pathogenic alteration in SMARCB1 or SMARCA4.Participants with extra-neural metastases/synchronous tumors (M4) are eligible. Participants of all ages are eligible. 2. Submission of tumor tissue, prior submission of tumor tissue to Children s Brain Tumor Network (CBTN), or report from a CLIA (or equivalent) approved laboratory with molecular subgroup analysis is mandatory (tissue may be from initial diagnosis or relapse). 3.Co-enrollment on Protocol for Children and Young Adults with a Central Nervous System (CNS) Tumor to Assess Cognitive, Quality of Life (QOL), and Comprehensive Effects of Therapies (PNOC-COMP) is strongly encouraged when subjects are eligible. 4.Participants may be alive or deceased. 5. A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
Exclusion criteria
Exclusion criteria: Participants without at least one of the following: tumor tissue available, tumor tissue previously submitted to CBTN, or an approved report with molecular subgroup determination from a either a CLIA certified laboratory or equivalent will not be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To analyze the significance of treatment, clinical and molecular variables in predicting progression free survival (PFS) at 6 months (PFS6) from date of diagnosis. 2.To create a well annotated ATRT biorepository for current and future studies through the collection of biospecimens, imaging and key clinical data.Timepoint: 1.About 6 months from each participant s study entry 2.5 years from last participant s enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Describe PFS and patterns of disease relapse/progression for children with recurrent/progressive ATRT.Timepoint: Enrollment (Baseline), 6m, 12m ( 6w), 18m ( 6w), 24m ( 6w), 30m ( 6w), 36m ( 6w), 48m ( 12w), 60m ( 12w).;Identify variables associated with overall survival (OS).Timepoint: Enrollment (Baseline), 6m, 12m ( 6w), 18m ( 6w), 24m ( 6w), 30m ( 6w), 36m ( 6w), 48m ( 12w), 60m ( 12w).;Determine if the use of clinical and molecular data to determine potential treatment options for participants with recurrent/progressive disease improves outcomes.Timepoint: Enrollment (Baseline), 6m, 12m ( 6w), 18m ( 6w), 24m ( 6w), 30m ( 6w), 36m ( 6w), 48m ( 12w), 60m ( 12w).;Assess correlation between metabolite profile on MRS and molecular subgroup.Timepoint: Enrollment and at 6m, 12m, 18m, 24m, 30m, 36m, 48m, 60m (when MRS performed as part of routine care).;Assess the ability to detect alterations in SMARCB1 or SMARCA4 in the CSF and serum of participants with ATRT.Timepoint: Enrollment and whenever blood/CSF is collected as part of routine clinical care.;Assess patient and/or proxy satisfaction with study participation via patient-reported outcome (PRO) measures in the context of race ethnicity and other health related social risks.Timepoint: Enrollment, 12m, 18m, 24m, 30m, 36m.;Assess therapy-associated toxicity in the context of race, ethnicity and other health related social risksTimepoint: Enrollment, 6m, 12m, 18m, 24m, 30m, 36m, 48m, 60m. | — |
Countries
Australia, Egypt, India, Israel, New Zealand, Switzerland, United States of America
Contacts
Public ContactDr TEJPAL GUPTA
Tata Memorial Hospital, Mumbai.
Outcome results
None listed