Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT01857934
Eligibility Criteria:
PARTICIPANT Inclusion Criteria:
* Participants \<19 years of age (eligible until 19th birthday).
* Newly diagnosed, advanced stage, high-risk neuroblastoma defined as one of the following:
* Children \< 1 year with International Neuroblastoma Staging System (INSS) stage 2a, 2b, 3, 4 or 4S disease AND MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal).
* INSS 2a or 2b disease AND MYCN amplification, regardless of age or additional biologic features
* INSS stage 3 AND:
1. MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal, regardless of age or additional biologic features
2. Age \> 18 months (\> 547 days) with unfavorable pathology, regardless of MYCN status
* INSS stage 4 and:
1. MYCN amplification, regardless of age or additional biologic features
2. Age \> 18 months (\> 547 days) regardless of biologic features
3. Age 12 - 18 months (365 - 547 days) with any of the following three unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index =1) or any biologic feature that is indeterminant/unknown
* Children at least 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy.
* Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines.
* Adequate renal and hepatic function (serum creatinine \<3 x upper limit of normal for age, AST\< 3 x upper limit of normal).
* No prior therapy, unless an emergency situation requires local tumor treatment (discuss with principal investigator).
* Written, informed consent according to institutional guidelines.
PARTICIPANT Exclusion Criteria:
* Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
* Pregnant or breast feeding (female of child-bearing potential).
* Children with INSS 4 disease, age \<18 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index \>1).
DONOR Inclusion Criteria:
* Potential donor is a biologic parent
* Potential donor is at least 18 years of age.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01857934
Study Brief:
Protocol Section:
NCT01857934