Beat Childhood Cancer Specimen Banking and Data Registry
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with suspected or confirmed pediatric solid tumors Patients with suspected or confirmed pediatric solid tumors |
Other: No intervention- registry only
No intervention- registry only
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri | United States | 63104 |
| 2 | Levine Children's Hospital | Charlotte | North Carolina | United States | 28204 |
| 3 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Study Chair: Giselle Sholler, MD, Beat Childhood Cancer at Atrium Health
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- LCI-BCC-BIO-001