DNA Biomarkers in Samples From Patients With Osteosarcoma and Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01139983|
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : May 18, 2016
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.
|Condition or disease||Intervention/treatment|
|Sarcoma||Genetic: DNA analysis Genetic: RNA analysis Genetic: fluorescence in situ hybridization Genetic: microarray analysis Genetic: polymerase chain reaction Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Observational Model:||Case Control|
|Official Title:||Search for Novel Genes in Osteosarcoma Revealed by Analysis of Tumour Copy-Number Alterations and Constitutional Copy-Number Variations|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||May 2016|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139983
|Principal Investigator:||David Malkin, MD||The Hospital for Sick Children|