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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.


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

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.


Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Role of copy-number alterations (CNAs) in the etiology of osteosarcoma
  2. Association between copy-number variations (CNVs) at chr7p14.1 and susceptibility to osteosarcoma
  3. Relationship between CNVs and tumor CNAs in osteosarcoma


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of osteosarcoma
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Malkin, MD The Hospital for Sick Children

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01139983     History of Changes
Other Study ID Numbers: AOST10B4
COG-AOST10B4 ( Other Identifier: Children's Oncology Group )
CDR0000674830 ( Other Identifier: Clinical Trials.gov )
NCI-2011-02234 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
osteosarcoma

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma