Skeletal Metastasis Registry

The International Skeletal Metastasis Registry

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05058014

Enrollment

Registered

2021-09-27

Start date

2018-08-16

Completion date

2023-12-06

Last updated

2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Bone Tumor

Keywords

Biopsy-proven or clinically-obvious metastatic bone disease

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results