Trial record 1 of 2 for:    AOST06B1
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Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00899275
First received: May 9, 2009
Last updated: August 5, 2014
Last verified: August 2014

May 9, 2009
August 5, 2014
February 2008
January 2100   (final data collection date for primary outcome measure)
  • Collect biological specimens from patients with osteosarcoma [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Provide a repository for long-term storage of osteosarcoma-related biological materials [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Make these specimens available to qualified researchers to understand the biology of osteosarcoma [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Correlate these results with the patients' clinical data [ Time Frame: lengh of study ] [ Designated as safety issue: No ]
  • Collect biological specimens from patients with osteosarcoma [ Designated as safety issue: No ]
  • Provide a repository for long-term storage of osteosarcoma-related biological materials [ Designated as safety issue: No ]
  • Make these specimens available to qualified researchers to understand the biology of osteosarcoma [ Designated as safety issue: No ]
  • Correlate these results with the patients' clinical data [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899275 on ClinicalTrials.gov Archive Site
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Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens

RATIONALE: Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.

PURPOSE: The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma.

OBJECTIVES:

  • To collect biological specimens from patients with osteosarcoma at Children's Oncology Group (COG) institutions.
  • To provide a repository for long-term storage of osteosarcoma-related biological materials.
  • To make these specimens available to qualified researchers to understand the biology of osteosarcoma and correlate these results with the patients' clinical data.

OUTLINE: After the initial submission of blood samples, patients may undergo open or closed biopsy in order to obtain fresh and frozen tissue samples as well as paraffin embedded material. Patients who are enrolled at the time of initial diagnosis but then have a definitive surgery or develop recurrent disease may submit additional samples (paraffin block, frozen and fresh tumor tissue, or slides together with blood samples). Autopsy tumor samples may also be submitted.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

serum, plasma and blood

Non-Probability Sample

All osteosarcoma patients seen at COG institutions

Sarcoma
Other: biologic sample preservation procedure
Ancillary/Correlative All patients
Intervention: Other: biologic sample preservation procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
January 2100   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • All osteosarcoma patients seen at COG institutions are eligible, including the following:

    • Newly diagnosed patients
    • Patients with recurrent disease who were not enrolled at the time of diagnosis
  • The following specimens from the initial biopsy (and/or definitive surgery if an up-front resection is performed) are required:

    • Paraffin embedded block OR 30 unstained slides
    • Pretreatment blood consisting of 5 mL serum, 10 mL plasma, and 10 mL heparinized whole blood
    • Fresh and frozen tumor specimens

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Patients are not required to enter a therapeutic study to enroll on this study
Both
Not Provided
No
United States,   Australia,   Canada,   New Zealand,   Puerto Rico
 
NCT00899275
AOST06B1, COG-AOST06B1, CDR0000562538
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Richard Gorlick, MD Children's Hospital at Montefiore
Children's Oncology Group
August 2014

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