Beat Childhood Cancer Specimen Banking and Data Registry

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715178
• Other study ID #: BCC-BIO-001
• Status: Recruiting
• Start date: February 2, 2021
• Est. completion date: January 2032

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Abigail Moore
• Phone: 7175310003
• Email: amoore13[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2032
• Est. primary completion date: January 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• No age restrictions

• Patients with suspected or confirmed pediatric 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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• No intervention- registry only
No intervention- registry only

Locations

Country	Name	City	State
United States	Dell Children's Blood and Cancer Center	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	Penn State Milton S. Hershey Medical Center and Children's Hospital	Hershey	Pennsylvania
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital of The King's Daughters	Norfolk	Virginia
United States	Randall Children's Hospital	Portland	Oregon
United States	St. Joseph's Children's Hospital	Tampa	Florida
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Giselle Sholler

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 years
Primary	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.	10 years
Primary	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.	10 years
Primary	Evaluate the correlation of baseline genomic alterations with clinical outcome.	Evaluate the correlation of baseline genomic alterations with clinical outcome.	10 years
Secondary	Bank additional specimens available for future research projects	Bank additional specimens available for future research projects	10 years
Secondary	Create cell line and xenograft models of pediatric cancers for future research	Create cell line and xenograft models of pediatric cancers for future research	10 years

External Links

•   Beat Childhood Cancer Consortium website