Trials / Completed
CompletedNCT01139983
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (estimated)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2016-05-01
- First posted
- 2010-06-09
- Last updated
- 2016-05-18
Source: ClinicalTrials.gov record NCT01139983. Inclusion in this directory is not an endorsement.