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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05058014
Other study ID # SIB1802
Secondary ID IRB00157231
Status Recruiting
Phase
First received
Last updated
Start date August 16, 2018
Est. completion date August 16, 2025

Study information

Verified date October 2023
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact Vaishali Laljani
Phone 410-502-2160
Email vparikh2@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 16, 2025
Est. primary completion date December 19, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Defense Health Programs with the U.S. Army Medical Research and Materiel Command, Murtha Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) OS (in months) calculated from the date of intervention. Up to 24 Months post surgery
Secondary Reoperation or retreatment for any reason Number of participants with reoperation or retreatment for any reason. Up to 24 24 months post surgery
Secondary Time to reoperation or retreatment for any reason Timing of reoperation calculated from the date of intervention. Up to 24 months post surgery
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