BCC-BIO-001: Beat Childhood Cancer Specimen Banking and Data Registry
Summary
This is an observational data registry study, also referred to as the “IN:Formation Project” of pediatric cancer patients at participating Beat Childhood Cancer Research Consortium sites involving specimen banking and data collection.
Trial Information
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. There are no age
restrictions on this study and all patients with suspected or confirmed pediatric tumors are eligible to enroll.
Approach
Primary Objective:
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.
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.
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.
Secondary Objectives:
Bank additional specimens available for future research projects
Create cell line and xenograft models of pediatric cancers for future research
Additional Information
NCT04715178
Full Details on ClinicalTrials.Gov
There are 18 Beat Childhood Cancer Research
Consortium Sites currently open to enrollment.
Eligibility
Inclusion Criteria:
No age restrictions
Subjects that fit into one of the following categories:
Subjects with suspected or confirmed cancers of childhood, adolescence, or young adulthood.
Survivors of a cancer of childhood, adolescence, or young adulthood (> 6 months off last therapy for cancer)
Subjects with a disease-matched condition
Healthy volunteers- including any participants with medical conditions that are not disease-matched.
Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).
Exclusion Criteria:
Subject or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
Contact Information
Principal Investigator: Giselle Sholler, MD
gsaulniersholler@pennstatehealth.psu.edu
Penn State Health Children’s Hospital, Hershey, Pennsylvania
Additional Contacts:
Email: BCCEnroll@pennstatehealth.psu.edu
Phone: (717) 531-0003