Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas

Observational - SNP Array Analysis of Undifferentiated Sarcomas

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01802125

Enrollment

Registered

2013-03-01

Start date

2013-02-28

Completion date

Unknown

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Sarcoma

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 description

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Observational model

CASE_CROSSOVER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Proportion of unclassifiable sarcomas that are unclassifiable	Baseline
Development of formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma	Baseline
Separate and distinct pathologic entities of undifferentiated sarcoma that are distinguishable by light microscopy, immunohistochemistry, SNP array profiling, or clinical features	Baseline
Specific actionable mutations that can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features	Baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026