UNC Childhood, Adolescent, and Young Adult Cancer Cohort (UNC-CAYACC)

Purpose: This study aims to create a registry of childhood, adolescent, and young adult patients with cancer (<40 years-old at cancer diagnosis), entitled the 'UNC Childhood, Adolescent, and Young Adult Cancer Cohort' (UNC-CAYACC). This resource will serve to support cancer outcomes research among pediatric and young adult cancer patients with a primary focus on enrolling patients treated as adolescents or young adults (AYAs, 15-39 years).

Procedures: As appropriate for age, participants will complete physical and cognitive functional assessments; questionnaires to assess health-related quality of life and other patient-reported outcomes; will undergo body composition and anthropometric measurements; and will be asked to provide biospecimens for biobanking. Assessments will be collected (as possible) at diagnosis, during active treatment, following treatment completion, and annually in survivorship to assess outcomes throughout the treatment and survivorship trajectory. Sociodemographic and clinical information such as cancer treatment modalities and cumulative doses will be collected by medical record abstraction. Participants will be eligible to enroll at any time from diagnosis through survivorship. This registry will provide data to better understand the manifestations of accelerated aging and key contributing factors among children, adolescents, and young adults with cancer.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Pediatric Cancer; Survivorship; Cancer Metastatic

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Andrew Smitherman, MD; Phone Number: 919-966-1178; Email: andrew_smitherman@med.unc.edu
• Study Contact Backup: Name: Lauren Lux, MSW; Phone Number: 984-974-8686; Email: lauren_lux@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina At Chapel Hill
      • Contact: Andrew Smitherman, MD; Phone Number: 919-966-1178; Email: andrew_smitherman@med.unc.edu
      • Contact: Lauren Lux, MSW; Phone Number: 984-974-8686; Email: lauren_lux@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Child, adolescent, and young adult (0-39 years-old at diagnosis, 1-39 years at enrollment) patients with cancer who will undergo or have undergone treatment or receive follow up care at the NC Children's Hospital, the NC Cancer Hospital, or one of the UNC Health affiliated clinical sites.

Description

Inclusion Criteria:

• Patient ages 0-39 years at the time of cancer diagnosis (ages 1-39 years at enrollment) who are at any point in treatment and survivorship trajectory
• English or Spanish speaking

Exclusion Criteria:

• Unwilling to sign informed consent
• Speak a language other than English or Spanish.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
UNC-CAYACC; Children, adolescents, and young adults diagnosed with cancer before the age of 40 enrolled at any point during the diagnosis-treatment-survivorship continuum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registry development	Creation of a registry of pediatric and young adult patients with cancer treated within the University of North Carolina Health System	Five years
Functional assessments	Assess feasibility for completing repeated physical and cognitive functional assessments among young cancer survivors. These assessments include measures of physical and general frailty.	Five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of sociodemographic, cancer, and treatment variables	Assess feasibility for collection of sociodemographic (including social determinants of health), cancer (e.g., site and stage), and treatment (e.g., modalities and cumulative doses) variables using patient questionnaires and medical record abstraction.	Five years
Collection of patient-reported outcome measures	Assess feasibility for the repeated collection of patient-reported measures of health-related quality of life, health behaviors, and functional status.	Five years

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Hyundai Hope On Wheels

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2031

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent and young adult; AYA
• Other Study ID Numbers: LCCC 2116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified aggregate data will be available upon request. De-identified or coded individual data from the registry may be made available upon request following completion of necessary data use agreements and with Institutional Review Board (IRB) approval.
• IPD Sharing Access Criteria: Data use inquiries should be directed to Andrew Smitherman, MD at andrew_smitherman@med.unc.edu. Requests will be reviewed and final decisions on release of data made by the UNC-CAYACC Governance and Data Sharing Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No