UNC Childhood, Adolescent, and Young Adult Cancer Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-39
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unwilling to sign informed consent

Speak a language other than English or Spanish.

Trial population

Child, adolescent, and young adult (0-39 years-old at diagnosis, 1-39 years at enrollment) patients with cancer who will undergo or have undergone treatment or receive follow up care at the NC Children's Hospital, the NC Cancer Hospital, or one of the UNC Health affiliated clinical sites.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: UNC-CAYACC

Trial outcomes

Primary outcomes

1

Registry development

Creation of a registry of pediatric and young adult patients with cancer treated within the University of North Carolina Health System

Time frame
Five years
2

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.

Time frame
Five years

Secondary outcomes

1

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.

Time frame
Five years
2

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.

Time frame
Five years

Other outcomes

Sponsors and contacts

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