Beat Childhood Cancer Specimen Banking and Data Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention- registry only.
- Who it may be relevant to
- Registry conditions: Pediatric Cancer, Survivorship. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers
Overview
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 subjects who have received molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, and to enable timely and informed treatment decisions by physicians for their cancers. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations that can be leveraged to offer more effective treatment. Findings may highlight additional areas of research 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 facilitate further advancement of this research.
Interventions
- Other No intervention- registry only
No intervention- registry only
Primary outcome measures
- Create a data registry of clinical and molecular/genomic data [Time frame: 10 Years]
- Determine number and types of genomic alterations within tumor types/subtypes [Time frame: 10 Years]
- Evaluate the rate of actionable genomic alternations [Time frame: 10 Years]
- Evaluate the correlation of baseline genomic alterations with clinical outcome. [Time frame: 10 Years]
- Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy. [Time frame: 10 Years]
Secondary outcome measures (4)
- Bank additional specimens available for future research projects [Time frame: 10 Years]
- Develop cell line and xenograft models of pediatric cancers for future research [Time frame: 10 Years]
- Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy. [Time frame: 10 Years]
- Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities. [Time frame: 10 Years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 18 centers
- Arkansas Children's Hospital — Little Rock
- Rady Children's Hospital — San Diego
- Connecticut Children's Hospital — Hartford
- Nicklaus Children's Miami — Miami
- Arnold Palmer Hospital for Children — Orlando
- St. Joseph's Children's Hospital — Tampa
- University of Iowa — Iowa City
- Norton Children's Research Institute/Affiliated with University of Louisville School of Me — Louisville
- … and 10 more centers
Identifiers
NCT: NCT04715178 · BCC-BIO-001