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.
Brief Title
Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Osteosarcoma
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT00899275
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
AOST06B1
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Children?s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
Primary Outcomes
Outcome Measure
Collection of biological specimens from patients with osteosarcoma
Outcome Time Frame
Baseline
Secondary Ids
Secondary Id
NCI-2009-00410
Secondary Id
CDR0000562538
Secondary Id
COG-AOST06B1
Secondary Id
AOST06B1
Secondary Id
AOST06B1
Secondary Id
U10CA098543
Secondary Id
UG1CA189958
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients diagnosed with osteosarcoma who are seen at COG institutions
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lisa Gennarini
Investigator Email
lfigueir@montefiore.org
Investigator Phone