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Clinical Trials/NCT05096923
NCT05096923
Recruiting
Not Applicable

UNC Childhood, Adolescent, and Young Adult Cancer Cohort

UNC Lineberger Comprehensive Cancer Center1 site in 1 country500 target enrollmentDecember 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Cancer
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
500
Locations
1
Primary Endpoint
Functional assessments
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 17, 2021
End Date
December 31, 2031
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

  • Collection of sociodemographic, cancer, and treatment variables(Five years)
  • Collection of patient-reported outcome measures(Five years)

Study Sites (1)

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