Beat Childhood Cancer Specimen Banking and Data Registry
- Conditions
- Pediatric Cancer
- Interventions
- Other: No intervention- registry only
- Registration Number
- NCT04715178
- Lead Sponsor
- Giselle Sholler
- Brief Summary
This is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- No age restrictions
- Patients with suspected or confirmed pediatric tumors
- Subject or his/her legally authorized representative (where applicable) signs the study consent.
- Patient or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with suspected or confirmed pediatric solid tumors No intervention- registry only Patients with suspected or confirmed pediatric solid tumors
- Primary Outcome Measures
Name Time Method Determine number and types of genomic alterations within tumor types/subtypes 10 years 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.
Create a data registry of clinical and molecular/genomic data 10 years 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.
Evaluate the rate of actionable genomic alternations 10 years Evaluate the rate of actionable genomic alternations resulting in associated targeted therapies relative to all actionable genomic alterations.
Evaluate the correlation of baseline genomic alterations with clinical outcome. 10 years Evaluate the correlation of baseline genomic alterations with clinical outcome.
- Secondary Outcome Measures
Name Time Method Bank additional specimens available for future research projects 10 years Bank additional specimens available for future research projects
Create cell line and xenograft models of pediatric cancers for future research 10 years Create cell line and xenograft models of pediatric cancers for future research
Trial Locations
- Locations (10)
Randall Children's Hospital
🇺🇸Portland, Oregon, United States
St. Joseph's Children's Hospital
🇺🇸Tampa, Florida, United States
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
Dell Children's Blood and Cancer Center
🇺🇸Austin, Texas, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Penn State Milton S. Hershey Medical Center and Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Children's Mercy Hospitals and Clinics
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States