Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma
Genetic Epidemiology of Ewing's Sarcoma
3 other identifiers
observational
1,650
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedJuly 14, 2016
July 1, 2016
3.6 years
June 10, 2013
July 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
Correlative studies
Ancillary studies
Eligibility Criteria
Patients with a diagnosis of Ewing Sarcoma meeting other criteria.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Monrovia, California, 91006-3776, United States
Related Publications (1)
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.
PMID: 36589413DERIVED
Biospecimen
saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Schiffman, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2013
First Posted
June 12, 2013
Study Start
December 1, 2012
Primary Completion
July 1, 2016
Last Updated
July 14, 2016
Record last verified: 2016-07