Molecular Analysis Of Solid Tumors (MAST)
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|ClinicalTrials.gov Identifier: NCT01050296|
Recruitment Status : Recruiting
First Posted : January 15, 2010
Last Update Posted : August 29, 2022
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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.
|Condition or disease|
|Pediatric Solid Tumors|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Molecular Analysis Of Solid Tumors|
|Actual Study Start Date :||February 10, 2010|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||September 30, 2024|
- 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 ]
- 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 years ]
- 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 years ]
- 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 years ]
- 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 years ]
- Compare micro RNAs in tumors. Micro RNAs will be isolated from the total [RNA] ribonucleic acid left over from the gene expression analysis described above. These samples will be used for micro [RNA] chip analysis or deep sequencing. [ Time Frame: 5 years ]
- Compare epigenetic modifications of [DNA] deoxyribonucleic acid. Genomic DNA will be isolated and DNA methylation will be analyzed across the genome to determine if this epigenetic process is altered in the tumor samples. [ Time Frame: 5 years ]
- Compare epigenetic modifications of chromatin. Cells will be rapidly fixed and chromatin will be prepared in order to directly probe protein-DNA complexes by [ChIP-seq]chromatin immunoprecipitation or [ChIP-chip analysis] chromatin immunoprecipitation [ Time Frame: 5 years ]
- Perform protein analysis. Tumor cells will be rapidly frozen for subsequent isolation of total protein or specific fraction of cellular proteins (i.e. nuclear, cytoplasmic, membrane proteins). [ Time Frame: 5 years ]
- Perform immunohistochemical and FISH analysis of neuroblastoma, osteosarcoma, retinoblastoma, ESFT and soft tissue sarcomas. Tissue microarrays will be prepared from samples collected in this study. [ Time Frame: 5 years ]
- Cell isolates obtained from primary and metastatic tumor specimens will be used to establish cell lines and orthotopic xenografts in immunocompromised mice. [ Time Frame: 5 years ]
- Perform analysis of cell growth, metastasis and sensitivity to chemotherapy. [ Time Frame: 5 years ]
- Evaluate the extent of immune cell infiltration and their functional status in pediatric solid tumors utilizing flow cytometric analysis of fresh tumor samples. [ Time Frame: 5 years ]
- Evaluate tumor-associated macrophages (TAMSs) post-therapy to locate gene expression patterns, markers and functional correlates of the tissue repair properties of macrophages in the post-therapy microenvironment. [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||up to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- Patient is known to be Hepatitis B, Hepatitis C and/or HIV positive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050296
|Contact: Sara M. Federico, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Sara M. Federico, MD 866-278-5833 email@example.com|
|Principal Investigator: Sara M. Federico, MD|
|Principal Investigator:||Sara M. Federico, MD||St. Jude Children's Research Hospital|
|Responsible Party:||St. Jude Children's Research Hospital|
|Other Study ID Numbers:||
DOD-W81XWH-14-1-0103(CA130396) ( Other Grant/Funding Number: DOD-Department of the Army )
|First Posted:||January 15, 2010 Key Record Dates|
|Last Update Posted:||August 29, 2022|
|Last Verified:||August 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Non-rhabdomyosarcoma soft tissue sarcoma