Molecular Analysis Of Solid Tumors
ConditionPediatric Solid Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 25
SponsorSt. Jude Children's Research Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient is known to be Hepatitis B, Hepatitis C and/or HIV positive.
Trial population
Patients identified at St. Jude Children's Research Hospital and collaborating institutions with a suspected or known diagnosis of neuroblastoma, osteosarcoma, retinoblastoma, Ewing sarcoma or soft tissue sarcoma based initial diagnostic workup and evidence of gross disease amenable to excision.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
Perform analysis of large chromosomal alterations such as amplifications and deletions. [DNA] deoxyribonucleic acid isolated from the tumor and blood samples will be hybridized to array [CGH] comparative genomic hybridization chips.
Time frame
5 years2
Perform analysis of focal alterations in the genome including amplification, deletion and loss of heterozygosity (LOH). DNA isolated from the tumor and blood samples will be hybridized to [SNP] single nucleotide polymorphism chips.
Time frame
5 years3
Perform analysis of point mutations. DNA isolated from the tumor and blood samples will be sequenced using next-generation sequencing technology to determine the sequence of the entire genome.
Time frame
5 years4
Perform analysis of cell morphology. Tissue samples will be fixed in a buffer suitable for transmission electron microscopy and processed for [TEM] transmission electron microscopy analysis.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Jude Children's Research Hospital
Lead sponsor
Alex's Lemonade Stand Foundation
Collaborator
Source ClinicalTrials.gov