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DNA Biomarkers in Samples From Patients With Osteosarcoma and Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01139983
First received: June 8, 2010
Last updated: March 1, 2011
Last verified: February 2011

June 8, 2010
March 1, 2011
February 2011
December 2012   (final data collection date for primary outcome measure)
  • Role of copy-number alterations (CNAs) in the etiology of osteosarcoma [ Designated as safety issue: No ]
  • Association between copy-number variations (CNVs) at chr7p14.1 and susceptibility to osteosarcoma [ Designated as safety issue: No ]
  • Relationship between CNVs and tumor CNAs in osteosarcoma [ Designated as safety issue: No ]
  • Role of CNAs in the etiology of osteosarcoma [ Designated as safety issue: No ]
  • Association between CNVs at chr7p14.1 and susceptibility to osteosarcoma [ Designated as safety issue: No ]
  • Relationship between CNVs and tumor CNAs in osteosarcoma [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01139983 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
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December 2012   (final data collection date for primary outcome measure)

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
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01139983
CDR0000674830, COG-AOST10B4
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Gregory H. Reaman, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Malkin, MD The Hospital for Sick Children
National Cancer Institute (NCI)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP