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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03057626
Registration number
NCT03057626
Ethics application status
Date submitted
15/02/2017
Date registered
20/02/2017
Date last updated
30/10/2023
Titles & IDs
Public title
Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
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Scientific title
LEAHRN (Late Effects After High-Risk Neuroblastoma) Study
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Secondary ID [1]
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NCI-2017-00170
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Secondary ID [2]
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ALTE15N2
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Recurrent Neuroblastoma
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Stage 2A Neuroblastoma
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Stage 2B Neuroblastoma
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Stage 3 Neuroblastoma
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Stage 4 Neuroblastoma
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Stage 4S Neuroblastoma
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Cytology Specimen Collection Procedure
Other interventions - Laboratory Biomarker Analysis
Other interventions - Quality-of-Life Assessment
Observational (specimen collection) - Patients undergo collection of blood and urine samples on day 1. Patients also undergo clinical assessments, laboratory, radiographic, and other ancillary studies on day 1.
Other interventions: Cytology Specimen Collection Procedure
Undergo collection of blood and urine
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Other interventions: Quality-of-Life Assessment
Ancillary studies
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of specific late effects
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Assessment method [1]
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Late effects of interest are organ dysfunction, subsequent malignant neoplasms (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction. Prevalence will be calculated as the number of patients with late effects divided by the number with known status of that endpoint.
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Timepoint [1]
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Up to 3 years
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Primary outcome [2]
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Risk factors of late effects
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Assessment method [2]
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Risk factors of interest include sex, race, ethnicity, current age, length of follow up, MYCN status, stage, primary site, age at diagnosis, total anthracycline dose (doxorubicin equivalents), cyclophosphamide dose equivalent categories, total platinum exposure (dose), topotecan exposure (yes [Y]/no [N]), cis-retinoic acid exposure (Y/N), GD-2/cytokine exposure (Y/N), radiation (Y/N), abdominal RT (Y/N), radiation to metastatic sites (Y/N), number of transplants, number of meta-iodobenzylguanidine (MIBG) scans, and therapeutic MIBG (Y/N). Will be reported as the number of patients with the risk factor divided by the number with known status of that risk factor for categorical variables and descriptively (mean, standard deviation) for continuous variables.
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Timepoint [2]
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Up to 3 years
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Primary outcome [3]
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Pediatric Quality of Life (PedsQL) score
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Assessment method [3]
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PedsQL score will be reported descriptively (mean, standard deviation). The proportion of patients with impaired physical growth, delayed pubertal development, chronic disease, impaired executive functioning, and impaired social functioning will also be reported.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [1]
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Collection and storage of blood samples
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Assessment method [1]
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Proportion of survivors and their families that consent for future utilization of their banked sample for future research will be reported.
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Timepoint [1]
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Up to 3 years
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Eligibility
Key inclusion criteria
- Patients must have been enrolled on COG neuroblastoma biology study ANBL00B1
- Patient must have been diagnosed with high-risk neuroblastoma per ANBL00B1 definition
- Patient must have been diagnosed on or after January 1, 2000
- At least 5 years must have elapsed since diagnosis
- Patients must have been treated for high-risk neuroblastoma
- Note: patients may have had any therapy for high-risk neuroblastoma, including
second line or non-established therapies (for example in the setting of less than
optimal initial response or concerns for high risk of relapse); patients may have
received therapy for refractory or relapsed neuroblastoma, or treatment for an
SMN; however all cytotoxic anti-neuroblastoma therapy should have been
administered >= 2 years of the enrollment date; SMN therapy may be completed or
ongoing at the time of enrollment
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Minimum age
5
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients must not be currently receiving active anti-neuroblastoma cytotoxic
chemotherapy
- Patients must not have received anti-neuroblastoma cytotoxic chemotherapy within the
last two years
- Note: cytotoxic therapies include (but are not limited to) chemotherapy (platinum
agents, alkylators, anthracyclines, topoisomerases, vinca alkaloids, other
cytotoxic chemotherapy), any kind of transplant, MIBG therapy, and/or radiation
therapy
- Non-cytotoxic (biologic/targeted/differentiating/other) therapies are permitted
at the time of enrollment; for example, patients receiving oral differentiating
agents, antiangiogenic therapy, immune modulators, holistic therapies,
difluoromethylornithine (DMFO), other minimal residual disease (MRD)
therapies/relapse-prevention therapies are eligible
- Patients with current active neuroblastoma relapse are ineligible
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
376
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment hospital [2]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Recruitment postcode(s) [2]
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6009 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This research trial studies late effects after treatment in patients with previously
diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide
which treatments for high-risk neuroblastoma are better tolerated with less side effects over
time.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03057626
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tara O Henderson
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Address
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Children's Oncology Group
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03057626
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