ClinicalTrials.gg
RecruitingNCT04715178Updated Feb 3, 2026

Beat Childhood Cancer Specimen Banking and Data Registry

An observational study in Pediatric Cancer and Survivorship, sponsored by Giselle Sholler. Recruiting at 18 sites in United States. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Giselle Sholler · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pediatric Cancer
  • Survivorship

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03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Giselle Sholler is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).

Exclusion criteria

Exclusion Criteria:

  • Subject or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with suspected or confirmed pediatric solid tumors

    Patients with suspected or confirmed pediatric solid tumors

    Other: No intervention- registry only

Interventions

  • OtherNo intervention- registry only

    No intervention- registry only

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 Years

  2. 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.

    Time frame: 10 Years

  3. 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.

    Time frame: 10 Years

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

    Evaluate the correlation of baseline genomic alterations with clinical outcome.

    Time frame: 10 Years

  5. 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.

    Time frame: 10 Years

Secondary outcomes

  1. Bank additional specimens available for future research projects

    Bank additional specimens available for future research projects

    Time frame: 10 Years

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

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

    Time frame: 10 Years

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

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

    Time frame: 10 Years

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

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

    Time frame: 10 Years

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Study locations

17 of 18 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04715178
Lead sponsor
Giselle Sholler
Responsible party
Giselle Sholler (Beat Childhood Cancer Chair, Milton S. Hershey Medical Center) — Sponsor-investigator
First posted
Jan 20, 2021
Start date
Feb 2, 2021
Primary completion
Jan 2031 (estimated)
Completion
Jan 2032 (estimated)
Last update
Feb 3, 2026

Study contacts

BCC Enroll
Contact
BCCEnroll@pennstatehealth.psu.edu
7175310003
Giselle Sholler, MD
study chair · Beat Childhood Cancer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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