DNA Biomarkers in Samples From Patients With Osteosarcoma and Healthy Volunteers
NCT ID: NCT01139983
Last Updated: 2016-05-18
Study Results
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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COMPLETED
90 participants
OBSERVATIONAL
2010-04-30
Brief Summary
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PURPOSE: This research study is studying DNA biomarkers in samples from patients with osteosarcoma and healthy volunteers.
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Detailed Description
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* To determine whether common copy-number alterations (CNAs) at chr7p14.1 arise de novo in osteosarcoma (OS) tumor DNA or whether they represent progression of constitutional copy-number variations (CNVs).
* To determine the association between constitutional CNVs at chr7p14.1 and susceptibility to OS.
* To determine how CNVs translate into CNAs in tumor DNA samples from patients with OS.
OUTLINE: RNA and DNA samples from banked blood and paired tumor tissue, plus samples from healthy controls, are analyzed for common copy-number alterations and constitutional copy-number variations (CNVs) at chr7p14.1 by microarray, q-PCR, RT-PCR, and FISH. Osteosarcoma predisposing CNVs results are then compared among cases versus healthy controls.
Clinical information associated with each osteosarcoma sample (i.e., gender, age of diagnosis, tumor site, tumor type and grade, presence of metastases at time of diagnosis, response to chemotherapy, event-free survival, and overall survival) is also collected, if available.
PROJECTED ACCRUAL: A total of 243 samples from patients with osteosarcoma and 80 samples from healthy controls will be accrued to this study.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Interventions
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DNA analysis
RNA analysis
fluorescence in situ hybridization
microarray analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David Malkin, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Other Identifiers
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COG-AOST10B4
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000674830
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02234
Identifier Type: REGISTRY
Identifier Source: secondary_id
AOST10B4
Identifier Type: -
Identifier Source: org_study_id
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