ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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 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
Actual Study Start Date : February 4, 2008
Estimated Primary Completion Date : January 1, 2100

Resource links provided by the National Library of Medicine


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




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

Biospecimen Retention:   Samples With DNA
serum, plasma and blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

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 180 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard Gorlick Children's Oncology Group

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899275     History of Changes
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: August 7, 2018
Last Verified: December 2017

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