Evaluating health outcomes in survivors of high-risk neuroblastoma
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
St. Jude Children's Research Hospital · NCT06480526
This study is testing how well survivors of high-risk neuroblastoma are doing more than two years after treatment by checking their health through various tests and looking at how their social circumstances might affect their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital (other) |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06480526 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of conducting comprehensive health evaluations for survivors of high-risk neuroblastoma who are more than two years post-therapy. Utilizing the established infrastructure of the St. Jude Lifetime Cohort Study, participants will undergo various tests, including blood tests, nervous system assessments, and ultrasounds, to evaluate their health outcomes. Additionally, the study will explore the relationship between these outcomes and social determinants of health. The goal is to gather valuable data on the long-term effects of contemporary therapies in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with high-risk neuroblastoma before the age of 18, treated at St. Jude Children's Research Hospital, and at least two years post-therapy.
Not a fit: Patients who have experienced a relapse or refractory disease during or after treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term health effects of neuroblastoma treatments, leading to improved care for survivors.
How similar studies have performed: Other studies have successfully evaluated long-term outcomes in cancer survivors, suggesting that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Sara Federico, MD — St. Jude Children's Research Hospital
- Study coordinator: Sara Federico, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: High-risk Neuroblastoma