UNC Childhood, Adolescent, and Young Adult Cancer Cohort

NCT ID: NCT05096923

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2031-12-31

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyundai Hope On Wheels

OTHER

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Smitherman, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrew Smitherman, MD

Role: CONTACT

andrew_smitherman@med.unc.edu

919-966-1178

Lauren Lux, MSW

Role: CONTACT

lauren_lux@med.unc.edu

984-974-8686

Facility Contacts

Andrew Smitherman, MD

Role: primary

andrew_smitherman@med.unc.edu

919-966-1178

Lauren Lux, MSW

Role: backup

lauren_lux@med.unc.edu

984-974-8686

Other Identifiers

LCCC 2116

Identifier Type: -

Identifier Source: org_study_id