Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction
September 1, 2011 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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conclusion of the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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conclusion of the study
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To determine if the presence of circulating osteosarcoma tumor cells is associated with patient outcome.
Time Frame: conclusion of the study
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conclusion of the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paul Meyers, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
December 24, 2007
First Submitted That Met QC Criteria
January 7, 2008
First Posted (Estimate)
January 8, 2008
Study Record Updates
Last Update Posted (Estimate)
September 2, 2011
Last Update Submitted That Met QC Criteria
September 1, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.