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Completed

NCT Number: NCT01876303

Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

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.

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Key information

Conditions

Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Monrovia, California, 91006-3776, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Main effect of gene polymorphisms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genetic Epidemiology of Ewing's Sarcoma

Important dates

Study start
2012
Primary completion
2016
First posted
Jun 12, 2013
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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