RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-10-21
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06480526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants were diagnosed with neuroblastoma at \< 18 years of age and categorized as high-risk at that time, according to INSS26 or INRGSS27 criteria.
  2. * Participants were treated for HR-NBL at SJCRH on NB2012 or as per NB2012.
  3. * Participants are ≥ 2 years from completion of therapy. Participants are 5 years of age or older.
  4. * Participant or legal guardian is able and willing to give informed consent.
  5. * 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.
  6. * Participants must also complete enrollment on SJLIFE.
  1. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  2. * Participants who had relapsed or refractory disease during or following completion of modern era treatment for HR-NBL.
  3. * Participants who are pregnant or breastfeeding.
  4. * Participants who are unable to read and understand English

Contacts and Locations

Study Contact

Sara Federico, MD
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

Sara Federico, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Sara Federico, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-10-21
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • High-risk Neuroblastoma