Metastatic Bone TumorNCT05058014
Skeletal Metastasis Registry
An observational study of Metastatic Bone Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Metastatic Bone Tumor
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 6 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic bone disease
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The International Skeletal Metastasis Registry
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)
Read the 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.
- Conditions
- Metastatic Bone Tumor
- Keywords
- Biopsy-proven or clinically-obvious metastatic bone disease
- Medical subject headings
- Bone Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS (in months) calculated from the date of intervention.
Measured: Up to 24 Months post surgery
Secondary outcomes (2)
Reoperation or retreatment for any reason
Number of participants with reoperation or retreatment for any reason.
Measured: Up to 24 24 months post surgery
Time to reoperation or retreatment for any reason
Timing of reoperation calculated from the date of intervention.
Measured: Up to 24 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start16 Aug 2018
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Why it stopped: The original investigator, Dr. Forsberg moved to MSKCC and plan to open the study there.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Bone TumorStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Murtha Cancer Center, Defense Health Programs with the U.S. Army Medical Research and Materiel Command
- Responsible party
- Sponsor
- Investigators
- Adam Levin, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058014
- Sponsor's protocol ID
- SIB1802
- Other IDs
- IRB00157231
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2021
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The International Skeletal Metastasis Registry
- ClinicalTrials.gov ID
- NCT05058014
- Acronym / sponsor ID
- SIB1802
- Conditions
- Metastatic Bone Tumor
- Keywords
- Biopsy-proven or clinically-obvious metastatic bone disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The original investigator, Dr. Forsberg moved to MSKCC and plan to open the study there.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Murtha Cancer Center, Defense Health Programs with the U.S. Army Medical Research and Materiel Command
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic bone disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: Up to 24 Months post surgery
OS (in months) calculated from the date of intervention.
2 secondary outcomes
Reoperation or retreatment for any reason
Time frame: Up to 24 24 months post surgery
Time to reoperation or retreatment for any reason
Time frame: Up to 24 months post surgery
Results and safety
The study was stopped early (reason given: The original investigator, Dr. Forsberg moved to MSKCC and plan to open the study there.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Levin, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Bone Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The original investigator, Dr. Forsberg moved to MSKCC and plan to open the study there.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 24 Months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.