NCT01139983

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying DNA biomarkers in samples from patients with osteosarcoma and healthy volunteers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Status
completed

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

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

6.1 years

First QC Date

June 8, 2010

Last Update Submit

May 17, 2016

Conditions

Sarcoma

Keywords

osteosarcoma

Outcome Measures

Primary Outcomes (3)

  • Role of copy-number alterations (CNAs) in the etiology of osteosarcoma

  • Association between copy-number variations (CNVs) at chr7p14.1 and susceptibility to osteosarcoma

  • Relationship between CNVs and tumor CNAs in osteosarcoma

Interventions

DNA analysisGENETIC
RNA analysisGENETIC
fluorescence in situ hybridizationGENETIC
microarray analysisGENETIC
polymerase chain reactionGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of osteosarcoma

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Diagnosis of osteosarcoma (OS) and meets 1 of the following criteria: * Original 153 OS samples, including paired germline and tumor DNA * Additional samples from 90 patients with OS: * Blood samples * Germline DNA * Paired tumor biopsy tissue (not from resection) obtained before systemic chemotherapy * Healthy controls, age- and gender-matched PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

SarcomaOsteosarcoma

Interventions

In Situ Hybridization, FluorescenceMicroarray AnalysisPolymerase Chain ReactionReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationMicrochip Analytical ProceduresNucleic Acid Amplification Techniques

Study Officials

  • David Malkin, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 9, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05