UNC-CAYACC: UNC Childhood, Adolescent, and Young Adult Cancer Cohort

Sponsor
UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05096923
Collaborator
Hyundai Hope On Wheels (Other)
500
1
120.4
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    UNC Childhood, Adolescent, and Young Adult Cancer Cohort
    Actual Study Start Date :
    Dec 17, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2031

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Registry development [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 [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 Outcome Measures

    1. Collection of sociodemographic, cancer, and treatment variables [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 [Five years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 39 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • UNC Lineberger Comprehensive Cancer Center
    • Hyundai Hope On Wheels

    Investigators

    • Principal Investigator: Andrew Smitherman, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UNC Lineberger Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05096923
    Other Study ID Numbers:
    • LCCC 2116
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by UNC Lineberger Comprehensive Cancer Center

    Study Results

    No Results Posted as of May 10, 2022