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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 : December 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Sarcoma Other: biologic sample preservation procedure

Detailed Description:

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.


Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
Study Start Date : February 2008
Estimated Primary Completion Date : January 2100

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Ancillary/Correlative All patients Other: biologic sample preservation procedure


Outcome Measures

Primary Outcome Measures :
  1. Collect biological specimens from patients with osteosarcoma [ Time Frame: baseline ]
  2. Provide a repository for long-term storage of osteosarcoma-related biological materials [ Time Frame: length of study ]
  3. Make these specimens available to qualified researchers to understand the biology of osteosarcoma [ Time Frame: length of study ]
  4. Correlate these results with the patients' clinical data [ Time Frame: lengh of study ]

Biospecimen Retention:   Samples With DNA
serum, plasma and blood

Eligibility Criteria

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All osteosarcoma patients seen at COG institutions
Criteria

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
Contacts and Locations

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


  Show 155 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Richard Gorlick, MD Children's Hospital at Montefiore
More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899275     History of Changes
Other Study ID Numbers: AOST06B1
COG-AOST06B1 ( Other Identifier: Children's Oncology Group )
NCI-2009-00410 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Children's Oncology Group:
osteosarcoma

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