Recruiting

Molecular AnalysisMolecular Analysis Of Solid Tumors

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT01050296

Conditions

Pediatric Solid Tumors

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pediatric Solid Tumors

Study ID

NCT01050296

Start date

Feb 10, 2010

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Perform analysis of gene expression profiles. [RNA] ribonucleic acid will be isolated from fresh frozen tumor specimens and hybridized to Affymetrix gene expression arrays. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Sara M. Federico, MD

1-866-278-5833 referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Sara M. Federico, MD

866-278-5833 referralinfo@stjude.org

Principal Investigator:

Sara M. Federico, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

Neuroblastoma
Retinoblastoma
Osteosarcoma
Rhabdomyosarcoma
Ewing sarcoma
Non-rhabdomyosarcoma soft tissue sarcoma
Adrenocortical tumors
Liver malignancies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2025-11-12.