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RecruitingObservational

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

NCT ID: NCT04715178Sponsor: Giselle ShollerLast updated: 2026-02-03

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.

Arms & interventions

  • OtherNo intervention- registry only

    No intervention- registry only

Outcome measures

Primary

  • 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

  • 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

  • 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

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

    Evaluate the correlation of baseline genomic alterations with clinical outcome.

    Time frame: 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.

    Time frame: 10 Years

Secondary

  • Bank additional specimens available for future research projects

    Time frame: 10 Years

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

    Time frame: 10 Years

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

    Time frame: 10 Years

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

    Time frame: 10 Years

Eligibility criteria

Sex: AllAge: All agesHealthy 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.

Study locations (18)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Recruiting
Susan Hall · Contact
Kevin Bielamowicz · Principal Investigator

Rady Children's Hospital

San Diego, California, 92123

Recruiting
Sarah Hollander · Contact
William Roberts · Principal Investigator

Connecticut Children's Hospital

Hartford, Connecticut, 06106

Recruiting
Adam Barselau · Contact
Michael Isakoff · Principal Investigator

Nicklaus Children's Miami

Miami, Florida, 33155

Recruiting
Aixa Guadarrama · Contact
Maggie Fader · Principal Investigator

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Recruiting
Marie Frankos · Contact
Jaime Libes-Bander · Principal Investigator

St. Joseph's Children's Hospital

Tampa, Florida, 33614

Recruiting
Jennifer Manns, RN · Contact
Don Eslin · Principal Investigator

University of Iowa

Iowa City, Iowa, 52242

Recruiting
Christopher Stamy · Contact
Sara Horton · Principal Investigator

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

Louisville, Kentucky, 40292

Recruiting
Jennifer Miller · Contact
Michael Ferguson · Principal Investigator

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, 55404

Recruiting
Pauline Mitby · Contact
Jawhar Rawwas · Principal Investigator

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Recruiting
Nicole Harvey · Contact
Kevin Ginn · Principal Investigator

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104

Recruiting
Gina Martin · Contact
William Ferguson · Principal Investigator

Levine Children's Hospital

Charlotte, North Carolina, 28204

Completed

AH Wake Forest Baptist - Brenner Children's Hospital

Winston-Salem, North Carolina, 27157

Recruiting
Graham Keyes · Contact
Mariah Wright-Nadkarni · Principal Investigator

Randall Children's Hospital

Portland, Oregon, 97227

Recruiting
Aaron White · Contact
Jason Glover · Principal Investigator

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

Hershey, Pennsylvania, 17033

Recruiting
Penn State Clinical Trials · Contact
Valerie Brown · Principal Investigator

Medical University of South Carolina

Charleston, South Carolina, 29425

Recruiting
Shanta Salzar, MD · Contact
Jaqueline Kraveka · Principal Investigator

Dell Children's Blood and Cancer Center

Austin, Texas, 78723

Recruiting
Rhea Robinson, RN · Contact
Michael Mitchell · Principal Investigator

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

Recruiting
Sabrina Wigginton · Contact
Wilson File · Principal Investigator