Bone MetastasesNCT01470105
Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases
An observational study of Bone Metastases, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The goal of this study is to improve how we estimate survival of people with cancer that has spread to their bone. There have been previous attempts to estimate survival of people with cancer that spread to the bone, but they have not been accurate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- blood sampling, the SF-36 questionnaire
- How many people
- 230 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential subjects will be recruited by the Orthopaedic Service of the Department of Surgery.
Who may be able to join
- ≥ to 18 years of age
- Diagnosed with a metastatic malignancy
- histologically proven in oligometastatic disease or by clinical suspicion in widely metastatic disease
- by conventional radiographs, cross sectional imaging and/or scintigraphy
- Scheduled for an orthopaedic operative intervention for skeletal metastases at MSKCC or Montefiore Medical Center including, not limited to the following:
- Resection
Show all 12Show fewer
- Intramedullary Fixation
- Prophylactic fixation
- Curettage and cementation
- Internal fixation
- Arthroplasty
- Spine stabilization
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Montefiore Medical Center
The Bronx, New York, 10467
About this study
The goal of this study is to improve how we estimate survival of people with cancer that has spread to their bone. There have been previous attempts to estimate survival of people with cancer that spread to the bone, but they have not been accurate. This study will try to improve the way we estimate survival in people with cancer that has spread to their bone by looking to see if a physician assessment and a patient assessment of the health status can be blended to give a better estimate of survival than patients or doctors alone.
- Conditions
- Bone Metastases
- Being tested
- blood sampling, the SF-36 questionnaire
- Keywords
- questionnaire, 11-121
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling, the SF-36 questionnaireOther
The patient be asked to fill out a questionnaire. The questionnaire asks about their quality of life and will take approximately 15 minutes to complete. It will be completed at a regularly scheduled clinic visit.
At the scheduled pre-operative testing, an extra sample of your blood (equal to about 4 teaspoons) will be collected for research tests. The research tests will measure levels of inflammation in your body. These tests are not part of routine care. A physical examination of the operative site will be done by the Orthopaedic Surgeon. The patient will complete the same questionnaire at the regularly scheduled three and six month follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| pts bone metastases | This is a prospective, cross sectional, human use study conducted using patients with bone metastases requiring orthopaedic stabilization. Though this is an observational study, blood sampling, the SF-36 questionnaire, and ECOG performance status, and correlative studies will be performed. Receives: Other: blood sampling, the SF-36 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum inflammatory cytokines
Whether the addition of serum inflammatory cytokines improves the robustness of an existing, validated Bayesian Belief network trained to estimate survival in human patients with operative skeletal metastases.
Measured: 3 years
Secondary outcomes (2)
chemokine analysis
Whether the addition of chemokine analysis improves the robustness of an existing, validated Bayesian Belief network trained to estimate survival in human patients with operative skeletal metastases.
Measured: 3 years
patient-reported SF-36 data
Whether the addition of and inclusion of patient-reported SF-36 data, improves the robustness of an existing, validated Bayesian Belief network trained to estimate survival in human patients with operative skeletal metastases.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Carol Morris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470105
- Sponsor's protocol ID
- 11-121
- Status last verified
- Jan 2026
- First submitted
- 9 Nov 2011
- Last updated
- 7 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases
- ClinicalTrials.gov ID
- NCT01470105
- Acronym / sponsor ID
- 11-121
- Conditions
- Bone Metastases
- Keywords
- questionnaire, 11-121
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Montefiore Medical Center
- Study start
- Nov 2011
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Nov 2011 (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.
The goal of this study is to improve how we estimate survival of people with cancer that has spread to their bone. There have been previous attempts to estimate survival of people with cancer that spread to the bone, but they have not been accurate. This study will try to improve the way we estimate survival in people with cancer that has spread to their bone by looking to see if a physician assessment and a patient assessment of the health status can be blended to give a better estimate of survival than patients or doctors alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pts bone metastases | – | Other: blood sampling, the SF-36 questionnaireThis is a prospective, cross sectional, human use study conducted using patients with bone metastases requiring orthopaedic stabilization. Though this is an observational study, blood sampling, the SF-36 questionnaire, and ECOG performance status, and correlative studies will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects will be recruited by the Orthopaedic Service of the Department of Surgery.
Key inclusion criteria (12 listed)
- ≥ to 18 years of age
- Diagnosed with a metastatic malignancy
- histologically proven in oligometastatic disease or by clinical suspicion in widely metastatic disease
- by conventional radiographs, cross sectional imaging and/or scintigraphy
- Scheduled for an orthopaedic operative intervention for skeletal metastases at MSKCC or Montefiore Medical Center including, not limited to the following:
Key exclusion criteria (1 listed)
- None
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 sampling, the SF-36 questionnaireThe patient be asked to fill out a questionnaire. The questionnaire asks about their quality of life and will take approximately 15 minutes to complete. It will be completed at a regularly scheduled clinic visit. At the scheduled pre-operative testing, an extra sample of your blood (equal to about 4 teaspoons) will be collected for research tests. The research tests will measure levels of inflammation in your body. These tests are not part of routine care. A physical examination of the operative site will be done by the Orthopaedic Surgeon. The patient will complete the same questionnaire at the regularly scheduled three and six month follow-up visit | Other | pts bone metastases |
Primary outcome
serum inflammatory cytokines
Time frame: 3 years
Whether the addition of serum inflammatory cytokines improves the robustness of an existing, validated Bayesian Belief network trained to estimate survival in human patients with operative skeletal metastases.
2 secondary outcomes
chemokine analysis
Time frame: 3 years
patient-reported SF-36 data
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Carol Morris, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases, run by Memorial Sloan Kettering Cancer Center at 2 sites 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 12 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
serum inflammatory cytokines (time frame: 3 years). 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 7 Jan 2026.