Clinical Trial: Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational - SNP Array Analysis of Undifferentiated Sarcomas

Brief Summary: This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

Detailed Summary:

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

PRIMARY OBJECTIVES:

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.

OUTLINE:

Tissue samples are analyzed for loss of heterozygosity (LOH) and SNP array profiling using microarray and immunohistochemistry.


Sponsor: Children's Oncology Group

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: February 27, 2013
Date Started: February 2013
Date Completion:
Last Updated: July 13, 2016
Last Verified: July 2016