Clinical trial NCT04715178: Beat Childhood Cancer Specimen Banking and Data Registry
Official title: Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Cancer
Survivorship
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric cancer subjects, survivorship, and healthy volunteers at The Pennsylvania State University and participating Beat Childhood Cancer Research Consortium sites.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Create a data registry of clinical and molecular/genomic data
timeFrame: 10 Years
measure: Determine number and types of genomic alterations within tumor types/subtypes
timeFrame: 10 Years
measure: Evaluate the rate of actionable genomic alternations
timeFrame: 10 Years
measure: Evaluate the correlation of baseline genomic alterations with clinical outcome.
timeFrame: 10 Years
measure: Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.
timeFrame: 10 Years
Secondary outcomes:
measure: Bank additional specimens available for future research projects
timeFrame: 10 Years
measure: Develop cell line and xenograft models of pediatric cancers for future research
timeFrame: 10 Years
measure: Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy.
timeFrame: 10 Years
measure: Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities.
timeFrame: 10 Years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Hartford
country: United States
facility: Connecticut Children's Hospital
state: Connecticut
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Portland
country: United States
facility: Randall Children's Hospital
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center and Children's Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Dell Children's Blood and Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters
state: Virginia
Study officials:
affiliation: Beat Childhood Cancer at Atrium Health
name: Giselle Sholler, MD
role: STUDY_CHAIR
References: