Beat Childhood Cancer Specimen Banking and Data Registry

Study Overview
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Brief Summary
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This is an observational data registry study of all pediatric cancer patients at Atrium Health (AH) and participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.

Detailed Description
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This observational registry and banking study is being performed on a large cohort of patients who have been identified to receive molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, enabling timely and informed treatment decisions by physicians for cancer patients. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations in tumors that can be leveraged to offer more effective treatment. Findings may suggest additional research will be required to better understand the molecular underpinnings of the relationship between molecular abnormalities and disease. Banked specimens and the creation of tumor cell lines and xenograft models will enable this research to be performed.

Official Title
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Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Other: No intervention- registry only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No age restrictions Patients with suspected or confirmed pediatric solid tumors Subject or his/her legally authorized representative (where applicable) signs the study consent. Exclusion Criteria: Patient or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected or confirmed pediatric solid tumors<br>Patients with suspected or confirmed pediatric solid tumors | Other: No intervention- registry only<br>* No intervention- registry only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create a data registry of clinical and molecular/genomic data | Create a data registry of clinical and molecular/genomic data from cancer patients who have undergone biopsy or surgical resection for clinical care to better understand the relationship between genomic and molecular information and clinical outcomes. | 10 years | 
| Determine number and types of genomic alterations within tumor types/subtypes | Define genomic landscape of pediatric cancers through the determination of the number and types of genomic alterations within tumor types/subtypes, across tumor types, and tumor evolution over time. | 10 years | 
| Evaluate the rate of actionable genomic alternations | Evaluate the rate of actionable genomic alternations resulting in associated targeted therapies relative to all actionable genomic alterations. | 10 years | 
| Evaluate the correlation of baseline genomic alterations with clinical outcome. | Evaluate the correlation of baseline genomic alterations with clinical outcome. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bank additional specimens available for future research projects | Bank additional specimens available for future research projects | 10 years | 
| Create cell line and xenograft models of pediatric cancers for future research | Create cell line and xenograft models of pediatric cancers for future research | 10 years |