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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:
National Cancer Institute (NCI)
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
History of Changes
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Search for Novel Genes in Osteosarcoma Revealed by Analysis of Tumour Copy-Number Alterations and Constitutional Copy-Number Variations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: February 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139983

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01139983     History of Changes
Other Study ID Numbers: CDR0000674830, COG-AOST10B4
Study First Received: June 8, 2010
Last Updated: March 1, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
osteosarcoma

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

ClinicalTrials.gov processed this record on May 21, 2013