UNC Childhood, Adolescent, and Young Adult Cancer Cohort

Cancer Clinical Trial

— UNC-CAYACC  

Official title:

UNC Childhood, Adolescent, and Young Adult Cancer Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05096923
• Other study ID #: LCCC 2116
• Status: Recruiting
• Start date: December 17, 2021
• Est. completion date: December 31, 2031

Study information

• Verified date: May 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Andrew Smitherman, MD
• Phone: 919-966-1178
• Email: andrew_smitherman[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2031
• Est. primary completion date: January 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cancer Metastatic
• Pediatric Cancer
• Survivorship

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Hyundai Hope On Wheels

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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