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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03057626




Registration number
NCT03057626
Ethics application status
Date submitted
15/02/2017
Date registered
20/02/2017
Date last updated
11/06/2020

Titles & IDs
Public title
Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
Scientific title
LEAHRN (Late Effects After High-Risk Neuroblastoma) Study
Secondary ID [1] 0 0
NCI-2017-00170
Secondary ID [2] 0 0
ALTE15N2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Neuroblastoma 0 0
Stage 2A Neuroblastoma 0 0
Stage 2B Neuroblastoma 0 0
Stage 3 Neuroblastoma 0 0
Stage 4 Neuroblastoma 0 0
Stage 4S Neuroblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of specific late effects - 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.
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Risk factors of late effects - 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.
Timepoint [2] 0 0
Up to 3 years
Primary outcome [3] 0 0
Pediatric Quality of Life (PedsQL) score - 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.
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Collection and storage of blood samples - Proportion of survivors and their families that consent for future utilization of their banked sample for future research will be reported.
Timepoint [1] 0 0
Up to 3 years

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
Minimum age
5 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [2] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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Iowa
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Kentucky
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
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Canada
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Alberta
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
State/province [39] 0 0
Ontario
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Canada
State/province [40] 0 0
Quebec
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New Zealand
State/province [41] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03057626
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tara O Henderson
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03057626