Beat Childhood Cancer Specimen Banking and Data Registry

September 26, 2023 updated by: Giselle Sholler

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This observational registry and banking study is being performed on a large cohort of patients who have been identified to receive molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, enabling timely and informed treatment decisions by physicians for cancer patients. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations in tumors that can be leveraged to offer more effective treatment. Findings may suggest additional research will be 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 enable this research to be performed.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Principal Investigator:
          • Kevin Bielamowicz, MD
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33614
        • Recruiting
        • St. Joseph's Children's Hospital
        • Principal Investigator:
          • Don Eslin, MD
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Kevin Ginn, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Children's Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Russell, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Sarah Supples, MD
        • Contact:
          • L
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Randall Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jason Glover, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Medical Center and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Valerie Brown, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Jaqueline Kraveka, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78723
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
        • Contact:
        • Principal Investigator:
          • Eric Lowe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric cancer patients at participating Beat Childhood Cancer Consortium sites

Description

Inclusion Criteria:

  • No age restrictions
  • Patients with suspected or confirmed pediatric solid tumors
  • Subject or his/her legally authorized representative (where applicable) signs the study consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected or confirmed pediatric solid tumors
Other: No intervention- registry only
No intervention- registry only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years
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.
10 years
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.
10 years
Evaluate the correlation of baseline genomic alterations with clinical outcome.
Time Frame: 10 years
Evaluate the correlation of baseline genomic alterations with clinical outcome.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bank additional specimens available for future research projects
Time Frame: 10 years
Bank additional specimens available for future research projects
10 years
Create cell line and xenograft models of pediatric cancers for future research
Time Frame: 10 years
Create cell line and xenograft models of pediatric cancers for future research
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giselle Sholler

Investigators

  • Study Chair: Giselle Sholler, MD, Beat Childhood Cancer at Atrium Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • LCI-BCC-BIO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Cancer

Clinical Trials on No intervention- registry only

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe