Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction

NCT00588510 | Completed

• 1 other identifier: 99-120
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteosarcoma

Keywords

Sarcoma; Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Blood draw OTHER

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.

Blood draw

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients less then three years of age
• Patients with Ewing's sarcoma, neuroblastoma and synovial sarcoma will be excluded from this protocol

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Osteosarcoma; Sarcoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul Meyers, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2007
• First Posted: January 8, 2008
• Study Start: January 1, 2000
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 2, 2011

Record last verified: 2011-09

Locations

US (1)