Skeletal Metastasis Registry | NCT05058014

Studies
Skeletal Metastasis Registry

NCT05058014

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Terminated

Last Update Posted

Oct 29, 2024Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Metastatic Bone Tumor

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB00157231	Other Identifier	Johns Hopkins Medicine

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The original investigator, Dr. Forsberg moved to MSKCC and plan to open the study there.

Expanded Access Info

Start Date

Aug 16, 2018Actual

Primary Completion Date

Dec 6, 2023Actual

Completion Date

Dec 6, 2023Actual

First Submitted Date

Aug 6, 2021

First Submission Date that Met QC Criteria

Sep 16, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2024

Last Update Posted Date

Oct 29, 2024Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Reoperation or retreatment for any reason	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with metastatic bone disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Levin, MD	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins		Baltimore	Maryland	20016	United States

Condition Browse Module

MeSH Terms

ID	Term
D001859	Bone Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided