Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases

Bone Metastases Clinical Trial

Official title:

Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01470105
• Other study ID #: 11-121
• Status: Active, not recruiting
• Start date: November 2011
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 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

• Intramedullary Fixation

• Prophylactic fixation

• Curettage and cementation

• Internal fixation

• Arthroplasty

• Spine stabilization

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

Other:
• blood sampling, the SF-36 questionnaire
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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	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.	3 years
Secondary	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.	3 years

External Links

•   Memorial Sloan Kettering Cancer Center