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, 2023
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Tracking Information | |||||
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First Submitted Date | January 14, 2010 | ||||
First Posted Date | January 15, 2010 | ||||
Last Update Posted Date | August 29, 2023 | ||||
Actual Study Start Date | February 10, 2010 | ||||
Estimated Primary Completion Date | September 30, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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 ] | ||||
Original Primary Outcome Measures |
Perform analysis of gene expression profiles. RNA will be isolated from fresh frozen tumor specimens and hybridized to Affymetrix gene expression arrays. [ Time Frame: 5 years ] | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Molecular Analysis Of Solid Tumors | ||||
Official Title | Molecular Analysis Of Solid Tumors | ||||
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. |
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Detailed Description | Each year approximately 2,200 children in the United States are diagnosed with neuroblastoma, osteosarcoma, Ewing sarcoma family of tumors (ESFT), retinoblastoma, soft tissue sarcomas, adrenocortical tumors and liver malignancies. These aggressive pediatric solid tumors are developmental tumors that initiate during periods of tissue growth and morphogenesis in the neural crest, bone and soft tissues. The overall survival rate of these tumors in the advanced stage is less than 30%. Despite intensive efforts over the past three decades using multiple therapeutic modalities including chemotherapy, surgery, radiation, autologous bone marrow transplant and biological agents there has been modest improvement in the long-term survival of these advanced stage pediatric solid tumors. A better understanding of the molecular, cellular and genetic changes that occur in the developing tissues as tumors form could improve the treatment of these devastating cancers. In particular, chemotherapeutic agents may be more effectively targeted to key regulatory enzymes or proteins if the study had a better understanding of the pathways that are disrupted as cells progress from preneoplastic lesions to metastatic disease. The specific aim of this proposal is to identify the changes in gene expression that occur in neuroblastoma, retinoblastoma, osteosarcoma, Ewing sarcoma family of tumors [ESFT] and soft tissue sarcoma cells and to correlate these changes with genetic and cellular changes in the tumor cells. [RNA] ribonucleic acid and genomic [DNA] deoxyribonucleic acid will be isolated from neuroblastoma, retinoblastoma, osteosarcoma, ESFT [Ewing sarcoma family of tumors] and soft tissue sarcomas (both primary and metastatic lesions) following surgery or bone marrow aspiration of previously untreated patients. Additional testing will be conducted on tumor samples at any point during or following therapy in which a surgical specimen is obtained. When there is sufficient tumor sample remaining after pathological analysis and banking, fresh primary tumor cells will be used to prepare orthotopic xenografts and to establish models of each disease that recapitulate the advanced forms of neuroblastoma, osteosarcoma, Ewing sarcoma family of tumors [ESFT], retinoblastoma and soft tissue sarcomas. For a small group of these excess samples, this study will perform fixation for electron microscopy and process the samples for [TEM] transmission electron microscopy analysis. These studies will complement our active research program characterizing the molecular, cellular and genetic features of genetically engineered mouse models of each of these diseases. Biological samples from the cohort of patients treated at St. Jude Children's Research Hospital will be complemented with samples collected and processed by collaborating institutions around the world. Samples collected from international collaborators will be used for analysis of [DNA] deoxyribonucleic acid and [RNA] ribonucleic acid to complement the St. Jude Children's Research Hospital cohort. Through this collaboration the study anticipates that they will be able to obtain enough fresh tumor samples to improve their understanding of multistage tumorigenesis in pediatric solid malignancies. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Tumor tissue - Tumor tissue will be obtained from patients with a diagnosis of neuroblastoma, retinoblastoma, osteosarcoma, Ewing sarcoma or soft tissue sarcoma at some or all of the following time points: initial biopsy, primary tumor resection, time of disease recurrence. Whole blood - 5 ml of whole blood will be collected from each patient and be used as a matched control. Bone marrow aspiration - 5ml of bone marrow will be taken at the time a patient is having a bone marrow aspirate performed and processed to remove only tumor cells.
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Sampling Method | Probability Sample | ||||
Study 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. | ||||
Condition | Pediatric Solid Tumors | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
1000 | ||||
Original Estimated Enrollment |
500 | ||||
Estimated Study Completion Date | September 30, 2024 | ||||
Estimated Primary Completion Date | September 30, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 25 Years (Child, Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | Chile | ||||
Administrative Information | |||||
NCT Number | NCT01050296 | ||||
Other Study ID Numbers | MAST DOD-W81XWH-14-1-0103(CA130396) ( Other Grant/Funding Number: DOD-Department of the Army ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | St. Jude Children's Research Hospital | ||||
Original Responsible Party | Michael A. Dyer, PhD, St. Jude Children's Research Hospital | ||||
Current Study Sponsor | St. Jude Children's Research Hospital | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Alex's Lemonade Stand Foundation | ||||
Investigators |
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PRS Account | St. Jude Children's Research Hospital | ||||
Verification Date | August 2023 |