Skeletal Metastasis Registry

Terminated

• Conditions: Metastatic Bone Tumor

• Registration Number: NCT05058014
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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)

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 Timeline

• Study Start: 2018-08-16
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Primary Completion: 2023-12-06
• Study Completion: 2023-12-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 24 Months post surgery	OS (in months) calculated from the date of intervention.

Secondary Outcome Measures

Name	Time	Method
Reoperation or retreatment for any reason	Up to 24 24 months post surgery	Number of participants with reoperation or retreatment for any reason.
Time to reoperation or retreatment for any reason	Up to 24 months post surgery	Timing of reoperation calculated from the date of intervention.

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States