Pediatric Cancer, Survivorship
Conditions
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 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
OTHERNo intervention- registry only
No intervention- registry only
Sponsors
Giselle Sholler
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* No age restrictions * Subjects that fit into one of the following categories: 1. Subjects with suspected or confirmed cancers of childhood, adolescence, or young adulthood. 2. Survivors of a cancer of childhood, adolescence, or young adulthood (\> 6 months off last therapy for cancer) 3. Subjects with a disease-matched condition 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy. | 10 Years | Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bank additional specimens available for future research projects | 10 Years | Bank additional specimens available for future research projects |
| Develop cell line and xenograft models of pediatric cancers for future research | 10 Years | Develop cell line and xenograft models of pediatric cancers for future research |
| Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy. | 10 Years | Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy. |
| Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities. | 10 Years | Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities. |
Countries
United States
Contacts
CONTACTBCC Enroll
STUDY_CHAIRGiselle Sholler, MD
Beat Childhood Cancer
Outcome results
None listed