Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

NCT ID: NCT01876303

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Schiffman, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Monrovia, California, United States

Site Status

Countries

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United States

References

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Zieger HK, Weinhold L, Schmidt A, Holtgrewe M, Juranek SA, Siewert A, Scheer AB, Thieme F, Mangold E, Ishorst N, Brand FU, Welzenbach J, Beule D, Paeschke K, Krawitz PM, Ludwig KU. Prioritization of non-coding elements involved in non-syndromic cleft lip with/without cleft palate through genome-wide analysis of de novo mutations. HGG Adv. 2022 Dec 5;4(1):100166. doi: 10.1016/j.xhgg.2022.100166. eCollection 2023 Jan 12.

Reference Type DERIVED
PMID: 36589413 (View on PubMed)

Other Identifiers

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NCI-2012-02210

Identifier Type: REGISTRY

Identifier Source: secondary_id

AEPI10N5

Identifier Type: OTHER

Identifier Source: secondary_id

AEPI10N5

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AEPI10N5

Identifier Type: -

Identifier Source: org_study_id

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