Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas

Soft Tissue Sarcoma Clinical Trial

Official title:

Observational - SNP Array Analysis of Undifferentiated Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802125
• Other study ID #: ARST12B9
• Secondary ID: NCI-2013-00489
• Status: Completed
• Phase: N/A
• First received: February 27, 2013
• Last updated: July 13, 2016
• Start date: February 2013

Study information

• Verified date: July 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of unclassifiable sarcomas that are unclassifiable		Baseline	No
Primary	Development of formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma		Baseline	No
Primary	Separate and distinct pathologic entities of undifferentiated sarcoma that are distinguishable by light microscopy, immunohistochemistry, SNP array profiling, or clinical features		Baseline	No
Primary	Specific "actionable mutations" that can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features		Baseline	No