Clinical trial · Observational
Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
LEAHRN (Late Effects After High-Risk Neuroblastoma) Study
NCT03057626CI-TRIAL-00100580active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
| Stage 2A Neuroblastoma | — | UNRESOLVED | — |
| Stage 2B Neuroblastoma | — | UNRESOLVED | — |
| Stage 3 Neuroblastoma | — | UNRESOLVED | — |
| Stage 4 Neuroblastoma | — | UNRESOLVED | — |
| Stage 4S Neuroblastoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (specimen collection)
- description
- 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.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
Primary outcomes (3)
- measure
- Prevalence of specific late effects
- timeFrame
- Up to 3 years
- description
- 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.
- measure
- Risk factors of late effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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 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
References
Publications (0)
Data not yet available
No reference posted for this study.