- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01567046
Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas
Observational - Potentially Actionable Mutations in Archived Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)
Study Overview
Status
Conditions
- Chordoma
- Desmoid Tumor
- Recurrent Childhood Soft Tissue Sarcoma
- Childhood Alveolar Soft-part Sarcoma
- Childhood Angiosarcoma
- Childhood Epithelioid Sarcoma
- Childhood Fibrosarcoma
- Childhood Leiomyosarcoma
- Childhood Liposarcoma
- Childhood Malignant Mesenchymoma
- Childhood Neurofibrosarcoma
- Childhood Synovial Sarcoma
- Metastatic Childhood Soft Tissue Sarcoma
- Nonmetastatic Childhood Soft Tissue Sarcoma
- Childhood Desmoplastic Small Round Cell Tumor
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of individual mutated genes in patients with NRSTS
Time Frame: Up to 1 month
|
Up to 1 month
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Genetic changes that are most common and likely to have the greatest therapeutic impact
Time Frame: Up to 1 month
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Up to 1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steve Skapek, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neuromuscular Diseases
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Neoplasms, Complex and Mixed
- Neoplasms, Connective Tissue
- Neoplasms, Vascular Tissue
- Neoplasms, Muscle Tissue
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Neoplasms, Adipose Tissue
- Neoplasms, Fibrous Tissue
- Neurofibroma
- Sarcoma
- Chordoma
- Leiomyosarcoma
- Liposarcoma
- Hemangiosarcoma
- Neurofibrosarcoma
- Sarcoma, Synovial
- Sarcoma, Alveolar Soft Part
- Fibrosarcoma
- Desmoplastic Small Round Cell Tumor
- Mesenchymoma
Other Study ID Numbers
- ARST12B5
- NCI-2012-00714 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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