Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) Clinical Trial

Official title:

Genetic Epidemiology of Ewing's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876303
• Other study ID #: AEPI10N5
• Secondary ID: NCI-2012-02210AE
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: July 13, 2016
• Start date: December 2012

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1650
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Family-Based, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Neuroectodermal Tumors, Primitive, Peripheral
• Sarcoma
• Sarcoma, Ewing

Intervention

Other:
• laboratory biomarker analysis
Correlative studies
• questionnaire administration
Ancillary 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	Main effect of gene polymorphisms	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.	Up to 5 years	No