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NCT Number: NCT04715178

Beat Childhood Cancer Specimen Banking and Data Registry

This is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention- registry only

Other

No intervention- registry only

Primary outcomes

  1. Create a data registry of clinical and molecular/genomic data

    Time frame: 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.

  2. Determine number and types of genomic alterations within tumor types/subtypes

    Time frame: 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.

  3. Evaluate the rate of actionable genomic alternations

    Time frame: 10 Years

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

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

    Time frame: 10 Years

    Evaluate the correlation of baseline genomic alterations with clinical outcome.

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

    Time frame: 10 Years

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

Secondary outcomes

  1. Bank additional specimens available for future research projects

    Time frame: 10 Years

    Bank additional specimens available for future research projects

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

    Time frame: 10 Years

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

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

    Time frame: 10 Years

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

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

    Time frame: 10 Years

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

Study contacts

Contact information is provided by the study sponsor or research team.

BCC Enroll

CONTACT

[email protected]

7175310003

Sponsors and collaborators

Lead sponsor

Giselle Sholler

Other

Registry information

Official study title

Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers

Important dates

Study start
2021
Primary completion
2031
Study completion
2032
First posted
Jan 20, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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