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Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma

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ClinicalTrials.gov Identifier: NCT00899275
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : March 24, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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

Condition or disease Intervention/treatment
Osteosarcoma Other: Cytology Specimen Collection Procedure

Detailed Description:

OBJECTIVES:

I. To collect biological specimens from patients with osteosarcoma at Children?s Oncology Group (COG) institutions.

II. To provide a repository for long-term storage of osteosarcoma-related biological materials.

III. 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.

Study Design
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Study Type : Observational
Actual Enrollment : 957 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Children?s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
Actual Study Start Date : February 4, 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Ancillary-correlative
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.
 Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling


Outcome Measures
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Primary Outcome Measures :
  1. Collection of biological specimens from patients with osteosarcoma [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Blood and tumor samples

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with osteosarcoma who are seen at COG institutions
Criteria

Inclusion Criteria:

  • 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
  • Patients are not required to enter a therapeutic study to enroll on this study
Contacts and Locations
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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): NCT00899275


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Richard G Gorlick Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899275    
Other Study ID Numbers: AOST06B1
NCI-2009-00410 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000562538
COG-AOST06B1
AOST06B1 ( Other Identifier: Childrens Oncology Group )
AOST06B1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma