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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date March 24, 2022
Actual Study Start Date February 4, 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: August 3, 2018)
Collection of biological specimens from patients with osteosarcoma [ Time Frame: Baseline ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • Collect biological specimens from patients with osteosarcoma
  • Provide a repository for long-term storage of osteosarcoma-related biological materials
  • Make these specimens available to qualified researchers to understand the biology of osteosarcoma
  • Correlate these results with the patients' clinical data
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
Official Title A Children?s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and tumor samples
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with osteosarcoma who are seen at COG institutions
Condition Osteosarcoma
Intervention Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling
Study Groups/Cohorts 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.
Intervention: Other: Cytology Specimen Collection Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 10, 2019)
957
Original Enrollment Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   New Zealand,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Children's Oncology Group
Original Responsible Party Not Provided
Current Study Sponsor Children's Oncology Group
Original Study Sponsor Same as current
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard G Gorlick Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date March 2022