Beat Childhood Cancer Specimen Banking and Data Registry

NCT04715178 | Recruiting

• 1 other identifier: BCC-BIO-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 18

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.

Conditions

Pediatric Cancer; Survivorship

Outcome Measures

Primary Outcomes (5)

• Create a data registry of clinical and molecular/genomic data

  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.

  10 Years

• Determine number and types of genomic alterations within tumor types/subtypes

  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.

  10 Years

• Evaluate the rate of actionable genomic alternations

  Evaluate the rate of actionable genomic alternations resulting in associated targeted therapies relative to all actionable genomic alterations.

  10 Years

• Evaluate the correlation of baseline genomic alterations with clinical outcome.

  Evaluate the correlation of baseline genomic alterations with clinical outcome.

  10 Years

• Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.

  Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.

  10 Years

Secondary Outcomes (4)

• Bank additional specimens available for future research projects

  10 Years

• Develop cell line and xenograft models of pediatric cancers for future research

  10 Years

• Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy.

  10 Years

• Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities.

  10 Years

Study Arms (1)

Patients with suspected or confirmed pediatric solid tumors

Patients with suspected or confirmed pediatric solid tumors

Other: No intervention- registry only

Interventions

No intervention- registry only OTHER

No intervention- registry only

Patients with suspected or confirmed pediatric solid tumors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric cancer subjects, survivorship, and healthy volunteers at The Pennsylvania State University and participating Beat Childhood Cancer Research Consortium sites.

You may qualify if:

• 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).

You may not qualify if:

• Subject or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.

Sponsors & Collaborators

• Giselle Sholler: lead

Study Sites (18)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

Connecticut Children's Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

Nicklaus Children's Miami

Miami, Florida, 33155, United States

RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

RECRUITING

St. Joseph's Children's Hospital

Tampa, Florida, 33614, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine

Louisville, Kentucky, 40292, United States

RECRUITING

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

RECRUITING

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

RECRUITING

Levine Children's Hospital

Charlotte, North Carolina, 28204, United States

COMPLETED

AH Wake Forest Baptist - Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Randall Children's Hospital

Portland, Oregon, 97227, United States

RECRUITING

Penn State Milton S. Hershey Medical Center and Children's Hospital

Hershey, Pennsylvania, 17033, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Dell Children's Blood and Cancer Center

Austin, Texas, 78723, United States

RECRUITING

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

RECRUITING

Related Links

• Beat Childhood Cancer Consortium website

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine, bone marrow, CSF, bucal swabs, tissue

MeSH Terms

Conditions

Neoplasms

Study Officials

• Giselle Sholler, MD

  Beat Childhood Cancer

  STUDY CHAIR

Central Study Contacts

BCC Enroll

CONTACT

7175310003; BCCEnroll@pennstatehealth.psu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Beat Childhood Cancer Chair

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: February 2, 2021
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (18)