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Recruiting

NCT Number: NCT05096923

UNC Childhood, Adolescent, and Young Adult Cancer Cohort

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.

Recruiting

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Key information

Age range

1 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Registry development

    Time frame: Five years

    Creation of a registry of pediatric and young adult patients with cancer treated within the University of North Carolina Health System

  2. Functional assessments

    Time frame: Five years

    Assess feasibility for completing repeated physical and cognitive functional assessments among young cancer survivors. These assessments include measures of physical and general frailty.

Secondary outcomes

  1. Collection of sociodemographic, cancer, and treatment variables

    Time frame: Five years

    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.

  2. Collection of patient-reported outcome measures

    Time frame: Five years

    Assess feasibility for the repeated collection of patient-reported measures of health-related quality of life, health behaviors, and functional status.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Smitherman, MD

CONTACT

[email protected]

919-966-1178

Lauren Lux, MSW

CONTACT

[email protected]

984-974-8686

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Hyundai Hope On Wheels

Registry information

Acronym: UNC-CAYACC

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Oct 27, 2021
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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