| NCT ID | NCT01050296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Pediatric Solid Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2010-02-10 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2010-02-10 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will prospectively characterize the molecular, cellular and genetic properties of primary and metastatic neuroblastoma, osteosarcoma, retinoblastoma, Ewing sarcoma family of tumors, soft tissue sarcomas, adrenocortical tumors and liver malignancies. These cell isolates will be used for gene expression array analysis, genomic analysis by \[SNP\] single nucleotide polymorphism chip, array \[CGH\] comparative genomic hybridization and next generation sequencing, and \[TEM\] transmission electron microscopy analysis. Additionally cell lines and orthotopic xenografts will be created from the obtained tumor specimens. The specificity of TCRs will be examined by comparing paired TCR from peripheral blood and tumor infiltrating CD4+ and CD8+ T cells. Epigenetic studies will be performed looking at the methylation profile of these cells and to investigate the anti-tumor T cell response both pre- and post-PD1 inhibition.
Eligibility Criteria
Inclusion Criteria: * Must have a suspected or known diagnosis of neuroblastoma, osteosarcoma, Ewing sarcoma family of tumor or soft tissue sarcoma based on the initial diagnostic workup and evidence of gross disease amenable to excision. Specimens may be collected at some or all of the following time points: initial biopsy, bone marrow aspiration procedures, tumor resection, and at time of possible relapse. * Patients with a diagnosis of retinoblastoma based on initial diagnostic workup and who require enucleation may be enrolled if there is no active therapeutic or biologic protocol for retinoblastoma. * The patient or his/her legal guardian, as appropriate, must provide written informed consent within 30 days of the removal of the first collection of tissue/bone marrow/blood sample for this protocol. * The patient is being seen at St. Jude Children's Research Hospital or at a collaborating institution. * Patients must be less than or equal to 25 years old at the time of enrollment. Exclusion Criteria: * Patient is known to be Hepatitis B, Hepatitis C and/or HIV positive.
Contact & Investigator
Sara M. Federico, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT01050296 clinical trial?
This trial is open to participants of all sexes, up to 25 Years, studying Pediatric Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01050296 currently recruiting?
Yes, NCT01050296 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT01050296 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT01050296 clinical trial?
NCT01050296 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Sara M. Federico, MD at St. Jude Children's Research Hospital. The trial plans to enroll 1,000 participants.