Feasibility of Screening for Early Late Effects of Contemporary Therapy in High-Risk Neuroblastoma Survivors

NCT ID: NCT06480526

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2028-12-31

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.

Conditions

High-risk Neuroblastoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Federico, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara Federico, MD

Role: CONTACT

referralinfo@stjude.org

866-278-5833

Facility Contacts

Sara Federico, MD

Role: primary

referralinfo@stjude.org

866-278-5833

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

NCI-2024-05183

Identifier Type: REGISTRY

Identifier Source: secondary_id

LEGACY

Identifier Type: -

Identifier Source: org_study_id