High-risk NeuroblastomaNCT06480526
Feasibility of Screening for Early Late Effects of Contemporary Therapy in High-Risk Neuroblastoma Survivors
An observational study of High-risk Neuroblastoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- High-risk Neuroblastoma
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
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
Read more
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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility will be measured by at least 66% participation rate
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). To establish the feasibility, we will estimate the participation rate. The study is considered to have an acceptable participation rate if the 95% lower bound of the participation rate exceeds 66%. Participation is defined as completing ≥ 75% of all proposed assessments.
Measured: Up to 24 months after participant enrollment.
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.
Participants will go through a comprehensive assessment including the SJLIFE core battery and additional studies in the categories of neurological and autonomic, immunological, quality of life, hematological, renal and metabolic, endocrine, cardiorespiratory, and gastrointestinal (see table below). Their health conditions will be defined by normative data and will be graded using the Revised Common Terminology Criteria for Adverse Events (CTCAE) used by Hudson et al. in SJLIFE studies. The prevalence, cumulative incidence, and latency of selected treatment complications in survivors will be estimated.
Resting/minimum/maximum heart rate, nerve velocities (median, deep peroneal, common peroneal, Sural), sweat total/baseline/end offset volumes, complete blood cou
Measured: Health outcomes will be assessed on Days 1, 2, 3, 4, or 5 during the SJLIFE and LEGACY campus visit.
Socioeconomic status will be measured by self-reported demographic information
Answers to the household survey, which includes single-item evaluations of self-reported race, ethnicity and primary language, collected per U.S. Health and Human Services guidelines, health literacy utilizing a validated 1-item screen, educational attainment, household materials hardship (HMH), and household income.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start21 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk NeuroblastomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Federico, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480526
- Sponsor's protocol ID
- LEGACY
- Other IDs
- NCI-2024-05183
- Status last verified
- May 2026
- First submitted
- 14 Jun 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480526
- Acronym / sponsor ID
- LEGACY
- Conditions
- High-risk Neuroblastoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility will be measured by at least 66% participation rate
Time frame: Up to 24 months after participant enrollment.
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). To establish the feasibility, we will estimate the participation rate. The study is considered to have an acceptable participation rate if the 95% lower bound of the participation rate exceeds 66%. Participation is defined as completing ≥ 75% of all proposed assessments.
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.
Time frame: Health outcomes will be assessed on Days 1, 2, 3, 4, or 5 during the SJLIFE and LEGACY campus visit.
Participants will go through a comprehensive assessment including the SJLIFE core battery and additional studies in the categories of neurological and autonomic, immunological, quality of life, hematological, renal and metabolic, endocrine, cardiorespiratory, and gastrointestinal (see table below). Their health conditions will be defined by normative data and will be graded using the Revised Common Terminology Criteria for Adverse Events (CTCAE) used by Hudson et al. in SJLIFE studies. The prevalence, cumulative incidence, and latency of selected treatment complications in survivors will be estimated. Resting/minimum/maximum heart rate, nerve velocities (median, deep peroneal, common peroneal, Sural), sweat total/baseline/end offset volumes, complete blood cou
Socioeconomic status will be measured by self-reported demographic information
Time frame: 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.
Answers to the household survey, which includes single-item evaluations of self-reported race, ethnicity and primary language, collected per U.S. Health and Human Services guidelines, health literacy utilizing a validated 1-item screen, educational attainment, household materials hardship (HMH), and household income.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Federico, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-risk Neuroblastoma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility will be measured by at least 66% participation rate (time frame: Up to 24 months after participant enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.