Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05096923

Conditions

Pediatric Cancer

Cancer

Cancer Metastatic

Survivorship

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05096923

Start date

Dec 17, 2021

Status verified date

May, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Jan 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Registry development [ Time Frame: Five years ]
  • Functional assessments [ Time Frame: Five years ]

Central Contacts and Locations

Central contacts

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Adolescent and young adult
  • AYA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-05-12.