Clinical trial NCT06480526: Feasibility of Screening for Early Late Effects of Contemporary Therapy in High-Risk Neuroblastoma Survivors
Official title: LEGACY (Late Effects of GD2 Antibody and Chemotherapy in Youths): Feasibility of Screening for Early Late Effects of Contemporary Therapy in High-Risk Neuroblastoma Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High-risk Neuroblastoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.

Brief summary: The study participant is being asked to be in a research study called LEGACY, because you were treated for high-risk neuroblastoma (HR-NBL).

Primary Objective

To determine the feasibility of conducting comprehensive evaluations, leveraging the established SJLIFE (St. Jude Lifetime Cohort Study) study infrastructure, in survivors of HR-NBL (high-risk neuroblastoma) who are greater than 2 years from completion of contemporary therapy and were previously treated at SJCRH (St. Jude Children's Research Hospital).

Exploratory Objectives

* To describe the health outcomes of survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy.
* To describe the relationship between patient outcomes and social determinants of health (SDOH) in survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy.

Detailed description: The study participant will have blood tests, tests to measure how your nervous system and stomach works, and an ultrasound of your liver for this study. The researchers will test how well your heart and blood vessels are working.

Eligibility criteria: Inclusion Criteria:

* Participants were diagnosed with neuroblastoma at \< 18 years of age and categorized as high-risk at that time, according to INSS26 or INRGSS27 criteria.
* Participants were treated for HR-NBL at SJCRH on NB2012 or as per NB2012.
* Participants are ≥ 2 years from completion of therapy. Participants are 5 years of age or older.
* Participant or legal guardian is able and willing to give informed consent.
* Participants may choose to participate in all or a fraction of the proposed assessments; refusal to participate in some aspects of the study will not preclude their inclusion.
* Participants must also complete enrollment on SJLIFE.

Exclusion Criteria:

* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Participants who had relapsed or refractory disease during or following completion of modern era treatment for HR-NBL.
* Participants who are pregnant or breastfeeding.
* Participants who are unable to read and understand English

Primary outcomes:
measure: Feasibility will be measured by at least 66% participation rate
timeFrame: Up to 24 months after participant enrollment.
measure: To describe the health outcomes of survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy.
timeFrame: Health outcomes will be assessed on Days 1, 2, 3, 4, or 5 during the SJLIFE and LEGACY campus visit.
measure: Socioeconomic status will be measured by self-reported demographic information
timeFrame: Socioeconomic status, assessed via the household survey, will be assessed on Days 1, 2, 3, 4, or 5 during the LEGACY and SJLIFE campus visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Sara Federico, MD
role: PRINCIPAL_INVESTIGATOR
References: