Beat Childhood Cancer Specimen Banking and Data Registry

Recruiting

• Conditions: Pediatric Cancer; Survivorship

• 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 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.

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-20
• Study Start: 2021-02-02
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2031-01
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Bank additional specimens available for future research projects	10 Years	Bank additional specimens available for future research projects
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.

Trial Locations

Locations (15)

Connecticut Children's Hospital; 🇺🇸 Hartford, Connecticut, United States

Arnold Palmer Hospital for Children; 🇺🇸 Orlando, Florida, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Cardinal Glennon Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Hasbro Children's Hospital; 🇺🇸 Providence, Rhode Island, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

St. Joseph's Children's Hospital; 🇺🇸 Tampa, Florida, United States

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States

Levine Children's Hospital; 🇺🇸 Charlotte, North Carolina, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

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