DNA Biomarkers in Samples From Patients With Osteosarcoma and Healthy Volunteers

Search for Novel Genes in Osteosarcoma Revealed by Analysis of Tumour Copy-Number Alterations and Constitutional Copy-Number Variations

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01139983

Enrollment

Registered

2010-06-09

Start date

2010-04-30

Completion date

Unknown

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

osteosarcoma

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.

Detailed description

OBJECTIVES: * 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.

Interventions

GENETICDNA analysis

GENETICRNA analysis

GENETICfluorescence in situ hybridization

GENETICmicroarray analysis

GENETICpolymerase chain reaction

GENETICreverse transcriptase-polymerase chain reaction

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026