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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03057626
Ethics application status
Date submitted
15/02/2017
Date registered
20/02/2017
Date last updated
29/10/2024

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
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Risk factors of late effects
Timepoint [2] 0 0
Up to 3 years
Primary outcome [3] 0 0
Pediatric Quality of Life (PedsQL) score
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Collection and storage of blood samples
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
Sex
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
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
Accrual to date
Final
376
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
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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Arkansas
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United States of America
State/province [4] 0 0
California
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United States of America
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Colorado
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United States of America
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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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United States of America
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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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United States of America
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Iowa
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United States of America
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Kentucky
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United States of America
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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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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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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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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
State/province [36] 0 0
Alberta
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Canada
State/province [37] 0 0
Manitoba
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Canada
State/province [38] 0 0
Nova Scotia
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
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/study/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/study/NCT03057626