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Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

Genetic Epidemiology of Ewing's Sarcoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01876303
Enrollment
1650
Registered
2013-06-12
Start date
2012-12-31
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

Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

OTHERquestionnaire administration

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
FAMILY_BASED
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Main effect of gene polymorphismsUp to 5 yearsRisk 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.

Countries

United States

Outcome results

None listed

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