NCT05058014

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

5.3 years

First QC Date

August 6, 2021

Last Update Submit

October 25, 2024

Conditions

Metastatic Bone Tumor

Keywords

Biopsy-proven or clinically-obvious metastatic bone disease

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    OS (in months) calculated from the date of intervention.

    Up to 24 Months post surgery

Secondary Outcomes (2)

  • Reoperation or retreatment for any reason

    Up to 24 24 months post surgery

  • Time to reoperation or retreatment for any reason

    Up to 24 months post surgery

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic bone disease

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 20016, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Adam Levin, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

September 27, 2021

Study Start

August 16, 2018

Primary Completion

December 6, 2023

Study Completion

December 6, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

US(1)