Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

Completed

• Conditions: Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)
• Interventions: Other: laboratory biomarker analysis; Other: questionnaire administration

• Registration Number: NCT01876303
• Lead Sponsor: Children's Oncology Group

Brief Summary

This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the association between the length of Ewing sarcoma breakpoint region 1-Friend leukemia virus integration 1 (EWS-FLI1) fusion protein binding sites (microsatellites) and risk of Ewing's sarcoma (ES).

II. To determine the frequency and commonality of Caucasian ancestral markers in cases of ES self-identified as non-Caucasian (African-American, Asian, Hispanic).

III. To determine the association between genomic variants in ES-related genes and hernia development (i.e. the integrin signaling pathway) and risk of ES.

OUTLINE:

Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-12
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1650

Inclusion Criteria

• The patient is enrolled on ACCRN07
• The patient has a diagnosis of Ewing Sarcoma (International Classification of Diseases [ICD] code morphology 9260; topography C40.0-C41.9, C76.0-C76.8, C80.9) and is registered with Children's Oncology Group (COG) by a North American member institution
• The patient must be diagnosed with Ewing sarcoma between December 24, 2007 and December 31, 2015
• The patient must have at least one biological parent alive and willing to participate
• All questionnaire respondents must understand English or Spanish
• Concomitant treatment on a therapeutic trial is not required

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (genetic epidemiology of Ewing sarcoma)	laboratory biomarker analysis	Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.
Ancillary-Correlative (genetic epidemiology of Ewing sarcoma)	questionnaire administration	Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.

Primary Outcome Measures

Name	Time	Method
Main effect of gene polymorphisms	Up to 5 years	Risk ratios (RR) for the main effect of gene polymorphisms will be calculated using log-linear models. RRs and 95% confidence intervals for the gene-environment interaction are calculated by stratifying the likelihood according to case exposure.

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States