Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas
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| ClinicalTrials.gov Identifier: NCT01567046 |
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Recruitment Status :
Completed
First Posted : March 30, 2012
Last Update Posted : May 17, 2016
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| Condition or disease | Intervention/treatment |
|---|---|
| Childhood Alveolar Soft-part Sarcoma Childhood Angiosarcoma Childhood Desmoplastic Small Round Cell Tumor Childhood Epithelioid Sarcoma Childhood Fibrosarcoma Childhood Leiomyosarcoma Childhood Liposarcoma Childhood Malignant Mesenchymoma Childhood Neurofibrosarcoma Childhood Synovial Sarcoma Chordoma Desmoid Tumor Metastatic Childhood Soft Tissue Sarcoma Nonmetastatic Childhood Soft Tissue Sarcoma Recurrent Childhood Soft Tissue Sarcoma | Other: laboratory biomarker analysis |
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Existing NRSTS samples from the COG D9902/ARST0332 studies Sampling Method: Non-Probability Sample
OBJECTIVES:
I. To determine the frequency with which actionable mutations are found in archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor specimens using mass spectrometry (MS) analysis of tumor-derived deoxyribonucleic acid (DNA).
OUTLINE:
Archived DNA tissue samples are analyzed for frequency of genetic mutations, including single nucleotide polymorphisms (SNPs), single nucleotide variants (SNVs), and small deletions and/or insertions, by polymerase chain reaction (PCR) and mass spectometry (Sequenom MassARRAY). Results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.
| Study Type : | Observational |
| Actual Enrollment : | 70 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Observational - Potentially Actionable Mutations in Archived Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) |
| Study Start Date : | May 2016 |
| Actual Primary Completion Date : | May 2016 |
| Actual Study Completion Date : | May 2016 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Correlative studies
Archived DNA tissue samples are analyzed for frequency of genetic mutations, including SNPs, SNVs, and small deletions and/or insertions, by PCR and mass spectometry (Sequenom MassARRAY). Results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.
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Other: laboratory biomarker analysis
Correlative studies |
- Frequency of individual mutated genes in patients with NRSTS [ Time Frame: Up to 1 month ]
- Genetic changes that are most common and likely to have the greatest therapeutic impact [ Time Frame: Up to 1 month ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | up to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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Archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor-derived DNA
- Synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST), soft tissue sarcoma not otherwise specified (NOS), or other less common pediatric NRSTS
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Formalin-fixed, paraffin-embedded (FFPE) tissue from patients enrolled on:
- COG-D9902 Soft Tissue Sarcoma (STS) Biology and Banking Protocol
- COG-ARST0332 A Risk-Based Treatment for Pediatric NRSTS Study
- See Disease Characteristics
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): NCT01567046
| United States, California | |
| Children's Oncology Group | |
| Monrovia, California, United States, 91006-3776 | |
| Principal Investigator: | Steve Skapek, MD | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01567046 |
| Other Study ID Numbers: |
ARST12B5 NCI-2012-00714 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
| First Posted: | March 30, 2012 Key Record Dates |
| Last Update Posted: | May 17, 2016 |
| Last Verified: | May 2016 |
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Sarcoma Leiomyosarcoma Liposarcoma Sarcoma, Synovial Chordoma Hemangiosarcoma Desmoplastic Small Round Cell Tumor Fibrosarcoma Sarcoma, Alveolar Soft Part Neurofibrosarcoma Mesenchymoma Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms, Muscle Tissue |
Neoplasms, Adipose Tissue Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Vascular Tissue Neurofibroma Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Peripheral Nervous System Neoplasms Nervous System Neoplasms Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neoplasms, Complex and Mixed |