Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas
|ClinicalTrials.gov Identifier: NCT01802125|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : July 14, 2016
|Condition or disease||Intervention/treatment|
|Soft Tissue Sarcoma||Other: laboratory biomarker analysis|
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients from ARST0332 study Sampling Method: Non-Probability Sample
I. To determine what proportion of unclassifiable sarcomas are unclassifiable because the initial evaluation was not sufficiently comprehensive versus what proportion can be regarded as "true" undifferentiated sarcoma when a comprehensive assessment has been performed.
II. To develop formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma.
III. To determine whether undifferentiated sarcoma can be subdivided into separate and distinct pathologic entities that are distinguishable by light microscopy, immunohistochemistry, single nucleotide polymorphism (SNP) array profiling, or clinical features.
IV. To determine whether undifferentiated sarcomas with specific "actionable mutations" can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features.
Tissue samples are analyzed for loss of heterozygosity (LOH) and SNP array profiling using microarray and immunohistochemistry.
|Study Type :||Observational|
|Estimated Enrollment :||49 participants|
|Official Title:||Observational - SNP Array Analysis of Undifferentiated Sarcomas|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||July 2014|
Basic science (SNP array analysis)
Tissue samples are analyzed using laboratory biomarker analysis for LOH and SNP array profiling using microarray and immunohistochemistry.
Other: laboratory biomarker analysis
- Proportion of unclassifiable sarcomas that are unclassifiable [ Time Frame: Baseline ]
- Development of formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma [ Time Frame: Baseline ]
- Separate and distinct pathologic entities of undifferentiated sarcoma that are distinguishable by light microscopy, immunohistochemistry, SNP array profiling, or clinical features [ Time Frame: Baseline ]
- Specific "actionable mutations" that can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features [ Time Frame: Baseline ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802125
|United States, California|
|Children's Oncology Group|
|Monrovia, California, United States, 91006-3776|
|Principal Investigator:||Julia Bridge, MD||Children's Oncology Group|