Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01876303
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : July 14, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) Other: laboratory biomarker analysis Other: questionnaire administration

Detailed Description:


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.


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

Study Type : Observational
Estimated Enrollment : 1650 participants
Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Genetic Epidemiology of Ewing's Sarcoma
Study Start Date : December 2012
Actual Primary Completion Date : July 2016

Group/Cohort Intervention/treatment
Ancillary-Correlative (genetic epidemiology of Ewing sarcoma)
Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.
Other: laboratory biomarker analysis
Correlative studies

Other: questionnaire administration
Ancillary studies

Primary Outcome Measures :
  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.

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of Ewing Sarcoma meeting other criteria.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01876303

United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Joshua Schiffman, MD Children's Oncology Group

Responsible Party: Children's Oncology Group Identifier: NCT01876303     History of Changes
Other Study ID Numbers: AEPI10N5
NCI-2012-02210 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AEPI10N5 ( Other Identifier: Children's Oncology Group )
AEPI10N5 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial