OsteosarcomaNCT00588510
Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction
An observational study of Osteosarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Blood draw
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Osteosarcoma patients seen in the Pediatrics Department or the Orthopedic Division of the Surgery Department at Memorial Sloan-Kettering Cancer Center
Who may be able to join
- 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
Who cannot join
- Patients less then three years of age
- Patients with Ewing's sarcoma, neuroblastoma and synovial sarcoma will be excluded from this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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
- Being tested
- Blood draw
- Keywords
- Sarcoma, Bone
- Medical subject headings
- Osteosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if circulating osteosarcoma cells can be reliably detected and quantitated in the blood of patients with localized and advanced osteosarcoma.
Measured: 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.
Measured: conclusion of the study
To determine if the presence of circulating osteosarcoma tumor cells is associated with patient outcome.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startJan 2000
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Meyers, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588510
- Sponsor's protocol ID
- 99-120
- Status last verified
- Sep 2011
- First submitted
- 24 Dec 2007
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Osteosarcoma Tumor Cells in the Blood of Patients Using the Polymerase Chain Reaction
- ClinicalTrials.gov ID
- NCT00588510
- Acronym / sponsor ID
- 99-120
- Conditions
- Osteosarcoma
- Keywords
- Sarcoma, Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood draw | – | Other: Blood drawPeripheral 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Osteosarcoma patients seen in the Pediatrics Department or the Orthopedic Division of the Surgery Department at Memorial Sloan-Kettering Cancer Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients less then three years of age
- Patients with Ewing's sarcoma, neuroblastoma and synovial sarcoma will be excluded from this protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawPeripheral 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. | Other | Blood draw |
Primary outcome
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
2 secondary outcomes
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
To determine if the presence of circulating osteosarcoma tumor cells is associated with patient outcome.
Time frame: conclusion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Related trials for Osteosarcoma
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Meyers, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2011.