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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Naval Medical Research Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01470105
First received: November 9, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Bone Metastases
Other: blood sampling, the SF-36 questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • serum inflammatory cytokines [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • chemokine analysis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • patient-reported SF-36 data [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood


Estimated Enrollment: 440
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Potential subjects will be recruited by the Orthopaedic Service of the Department of Surgery.

Criteria

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 including, not limited to the following:
  • Resection
  • Intramedullary Fixation
  • Prophylactic fixation
  • Curettage and cementation
  • Internal fixation
  • Arthroplasty
  • Spine stabilization

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470105

Contacts
Contact: John Healey, MD 212-639-7611
Contact: Patrick Boland, MD 212-639-8684

Locations
United States, Maryland
Naval Medical Research Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Jonathan Agner Forsberg, MD    301-319-9788    Jonathan.A.Forsberg@health.mil   
Principal Investigator: Jonathan Agner Forsberg, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue Recruiting
New York, New York, United States, 10021
Contact: John Healey, MD    212-639-7611      
Contact: Patrick Boland, MD    212-639-8684      
Principal Investigator: John Healey, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Naval Medical Research Center
Investigators
Principal Investigator: John Healey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01470105     History of Changes
Other Study ID Numbers: 11-121
Study First Received: November 9, 2011
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
questionnaire
11-121

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014