Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction
Study Details
Study Description
Brief Summary
This study focusses on finding out if osteosarcoma can be detected in blood. The cells will be measured by a new laboratory technique called the polymerase chain reaction. This new technique can identify one tumor cell among one million normal cells. Using this technique Memorial Sloan-Kettering Cancer Center research doctors may be able to detect tumor cells that could not be identified any other way. This test will be in addition to cancer treatment and will not replace any other test used normally. As this technique is still unproved the results will not be given to patients or patient's doctors and will not be used to change cancer treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Blood draw Peripheral blood samples (6-9 ml) will be collected in purple top tubes, when routine laboratory tests are being drawn. The blood will be drawn through central venous catheters, whenever possible. |
Other: Blood draw
Peripheral blood samples (6-9 ml) will be collected in purple top tubes, when routine laboratory tests are being drawn. The blood will be drawn through central venous catheters, whenever possible. Blood will be drawn once from patients with malignant diagnoses other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma. In patients with osteosarcoma we will obtain blood when baseline laboratory tests are obtained, after every two cycles of treatment (approximately every six weeks), at the end of planned surgery and chemotherapy, every three months for the first year off therapy and yearly thereafter. We will also obtain blood if the patient relapses.
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Outcome Measures
Primary Outcome Measures
- To determine if circulating osteosarcoma cells can be reliably detected and quantitated in the blood of patients with localized and advanced osteosarcoma. [conclusion of the study]
Secondary Outcome Measures
- To determine the frequency circulating osteosarcoma cells can be detected in the blood of patients at diagnosis, during therapy, at the completion of all planned therapy and at relapse. [conclusion of the study]
- To determine if the presence of circulating osteosarcoma tumor cells is associated with patient outcome. [conclusion of the study]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with osteosarcoma are the study group
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Patients with malignant diagnoses other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma may participate as controls
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Histologically proven osteosarcoma or a history of histologically proven osteosarcoma are eligible for participation. The patient does not need to be newly diagnosed for enrollment on this protocol
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Patients with malignant diagnosis other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma are eligible to participate if they have a central venous catheter and routine blood work is being drawn
Exclusion Criteria:
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Patients less then three years of age
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Patients with Ewing's sarcoma, neuroblastoma and synovial sarcoma will be excluded from this protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Paul Meyers, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 99-120