UNC Childhood, Adolescent, and Young Adult Cancer Cohort

NCT05096923 | Recruiting

• 1 other identifier: LCCC 2116
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer; Cancer; Cancer Metastatic; Survivorship

Keywords

Adolescent and young adult; AYA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Collection of sociodemographic, cancer, and treatment variables

  Five years

• Collection of patient-reported outcome measures

  Five years

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Year - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Hyundai Hope On Wheels: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Up to 22.5 milliliters of peripheral blood

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Smitherman, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Smitherman, MD

CONTACT

919-966-1178; andrew_smitherman@med.unc.edu

Lauren Lux, MSW

CONTACT

984-974-8686; lauren_lux@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: December 17, 2021
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)