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Observational - SNP Array Analysis of Undifferentiated Sarcomas


N/A
N/A
N/A
Not Enrolling
Both
Soft Tissue Sarcoma

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Trial Information

Observational - SNP Array Analysis of Undifferentiated Sarcomas


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.


Inclusion Criteria:



- 49 cases of undifferentiated sarcomas from ARST0332 (additional cases may be
ascertained as eligible for this current project that also fall under ARST0332 to be
requested later if necessary)

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Retrospective

Outcome Measure:

Proportion of unclassifiable sarcomas that are unclassifiable

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Julia Bridge

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

ARST12B9

NCT ID:

NCT01802125

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Soft Tissue Sarcoma
  • Sarcoma

Name

Location

Children's Oncology GroupArcadia, California  91006-3776