Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588510
First received: December 24, 2007
Last updated: September 1, 2011
Last verified: September 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Osteosarcoma |
Other: Blood draw |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- To determine if the presence of circulating osteosarcoma tumor cells is associated with patient outcome. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
| Enrollment: | 59 |
| Study Start Date: | January 2000 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Osteosarcoma patients seen in the Pediatrics Department or the Orthopedic Division of the Surgery Department at Memorial Sloan-Kettering Cancer Center
Criteria
Inclusion Criteria:
- Patients with osteosarcoma are the study group
- Patients with malignant diagnoses other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma may participate as controls
- 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
- 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:
- Patients less then three years of age
- Patients with Ewing's sarcoma, neuroblastoma and synovial sarcoma will be excluded from this protocol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588510
Locations
| United States, New York | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00588510 History of Changes |
| Other Study ID Numbers: | 99-120 |
| Study First Received: | December 24, 2007 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Sarcoma Bone |
Additional relevant MeSH terms:
|
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma |
ClinicalTrials.gov processed this record on October 17, 2012
