Recruiting

Observational Study

Sponsor:

Giselle Sholler

Code:

NCT04715178

Conditions

Pediatric Cancer

Survivorship

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

No intervention- registry only

Study Details

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

Study ID

NCT04715178

Start date

Feb 2, 2021

Status verified date

Jan, 2026

Completion date

Jan, 2032

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with suspected or confirmed pediatric solid tumors

Patients with suspected or confirmed pediatric solid tumors

Interventions

No intervention- registry only

No intervention- registry only

Primary outcome measure

  • Create a data registry of clinical and molecular/genomic data [ Time Frame: 10 Years ]
  • Determine number and types of genomic alterations within tumor types/subtypes [ Time Frame: 10 Years ]
  • Evaluate the rate of actionable genomic alternations [ Time Frame: 10 Years ]
  • 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. [ Time Frame: 10 Years ]

Central Contacts and Locations

Central contacts

BCC Enroll

7175310003BCCEnroll@pennstatehealth.psu.edu

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Susan Hall

HallSF@archildrens.org

Principal Investigator:

Kevin Bielamowicz

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Sarah Hollander

shollander@rchsd.org

Principal Investigator:

William Roberts

Connecticut Children's Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Adam Barselau

Abarselau@connecticutchildrens.org

Principal Investigator:

Michael Isakoff

Nicklaus Children's Miami

Recruiting

Miami, Florida, United States, 33155

Contacts

Aixa Guadarrama

Aixa.Guadarrama@Nicklaushealth.org

Principal Investigator:

Maggie Fader

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Marie Frankos

marie.frankos@orlandohealth.com

Principal Investigator:

Jaime Libes-Bander

St. Joseph's Children's Hospital

Recruiting

Tampa, Florida, United States, 33614

Contacts

Jennifer Manns, RN

jennifer.manns@baycare.org

Principal Investigator:

Don Eslin

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Christopher Stamy

chris-stamy@uiowa.edu

Principal Investigator:

Sara Horton

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

Recruiting

Louisville, Kentucky, United States, 40292

Contacts

Jennifer Miller

Jennifer.Miller4@nortonhealthcare.org

Principal Investigator:

Michael Ferguson

Children's Hospital and Clinics of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Pauline Mitby

pauline.mitby@childrensmn.org

Principal Investigator:

Jawhar Rawwas

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Nicole Harvey

ndharvey@cmh.edu

Principal Investigator:

Kevin Ginn

Cardinal Glennon Children's Hospital

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Gina Martin

gina.martin@health.slu.edu

Principal Investigator:

William Ferguson

AH Wake Forest Baptist - Brenner Children's Hospital

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Graham Keyes

grkeyes@wakehealth.edu

Principal Investigator:

Mariah Wright-Nadkarni

Randall Children's Hospital

Recruiting

Portland, Oregon, United States, 97227

Contacts

Aaron White

AJWHITE@lhs.org

Principal Investigator:

Jason Glover

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

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Penn State Clinical Trials

ExtractClinicalTrials@pennstatehealth.psu.edu

Principal Investigator:

Valerie Brown

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Shanta Salzar, MD

salzers@musc.edu

Principal Investigator:

Jaqueline Kraveka

Dell Children's Blood and Cancer Center

Recruiting

Austin, Texas, United States, 78723

Contacts

Rhea Robinson, RN

rmrobinson@ascension.org

Principal Investigator:

Michael Mitchell

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Sabrina Wigginton

Sabrina.Wigginton@chkd.org

Principal Investigator:

Wilson File

More Information

Sponsor

Giselle Sholler

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Giselle Sholler on 2026-02-03.