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

Recruiting
Conditions
Registration Number
NCT06480526
Lead Sponsor
St. Jude Children's Research Hospital
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
...

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
45
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.
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Feasibility will be measured by at least 66% participation rateUp 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 es...

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.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 an...

Socioeconomic status will be measured by self-reported demographic informationSocioeconomic 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

St. Jude Children's Research Hospital

🇺🇸

Memphis, Tennessee, United States

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