Skeletal Metastasis Registry

October 25, 2024 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

The International Skeletal Metastasis Registry

This is a prospective, observational study designed to contribute data from patients with symptomatic metastatic bone disease treated at Sibley Memorial Hospital and Johns Hopkins Medicine to an international registry hosted by the Swedish Regional Cancer Centrum in Stockholm, Sweden. This protocol supports a worldwide effort to collect and store information from patients treated for symptomatic bone metastases within the International Skeletal Metastasis Registry (ISMR)

Study Overview

Status

Terminated

Conditions

Detailed Description

The registry is designed to update a suite of clinical decision-support tools designed for use when treating patients with metastatic bone disease. The models estimate the likelihood of survival at 1, 3, 6, 12, 18, and 24 months post surgery, which in turn, may be used for surgical decision-making.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 20016
        • Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic bone disease

Description

Inclusion Criteria:

  • Adult patients, age 22 or older
  • Biopsy-proven or clinically-obvious metastatic bone disease
  • Symptomatic bone lesion requiring intervention o Including, not limited to, radiotherapy, cryotherapy, radiofrequency ablation, operative fixation, prosthetic replacement, amputation, or any combination of the above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 24 Months post surgery
OS (in months) calculated from the date of intervention.
Up to 24 Months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation or retreatment for any reason
Time Frame: Up to 24 24 months post surgery
Number of participants with reoperation or retreatment for any reason.
Up to 24 24 months post surgery
Time to reoperation or retreatment for any reason
Time Frame: Up to 24 months post surgery
Timing of reoperation calculated from the date of intervention.
Up to 24 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Murtha Cancer Center
Defense Health Programs with the U.S. Army Medical Research and Materiel Command

Investigators

  • Principal Investigator: Adam Levin, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2018

Primary Completion (Actual)

December 6, 2023

Study Completion (Actual)

December 6, 2023

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIB1802
  • IRB00157231 (Other Identifier: Johns Hopkins Medicine)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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