Clinical trial NCT05096923: UNC Childhood, Adolescent, and Young Adult Cancer Cohort
Official title: UNC Childhood, Adolescent, and Young Adult Cancer Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Cancer
Cancer
Cancer Metastatic
Survivorship
Keywords: Adolescent and young adult
AYA
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Hyundai Hope On Wheels
First posted: 2021-10-27
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


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.

Primary outcomes:
measure: Registry development
timeFrame: Five years
measure: Functional assessments
timeFrame: Five years
Secondary outcomes:
measure: Collection of sociodemographic, cancer, and treatment variables
timeFrame: Five years
measure: Collection of patient-reported outcome measures
timeFrame: Five years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Andrew Smitherman, MD
role: PRINCIPAL_INVESTIGATOR
References: