Bone TumorNCT04755140
Endoprosthesis Metal Toxicity Study
An observational study of Bone Tumor and Cancer of Bone, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Tumor, Cancer of Bone, Heart Diseases
- What is being tested?
- Questionnaires, Interviews and Blood Test
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 1 May 2024
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 150 patients to complete cardiology part of the study (questionnaires, blood test, echocardiogram). 150 patients to complete cognitive part of the study (questionnaires, interviews, blood test). Patient groups may overlap.
Who may be able to join
- Patient has an endoprosthesis after extremity malignancy
Who cannot join
- Current fracture or infection around the endoprosthesis
- Patient is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis
The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur.
Read the detailed description
At your first visit you will be asked to do the following:
- Sign the consent document.
- Patient Interview: An interview will be conducted by the study coordinator on the research team. They will ask your past surgical history, health history, medications, and your cognition.
- Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
- Memory Interview: You will be evaluated on your memory and thinking skills three total times. One to determine baseline, and then repeated at one year and two years. You will answer questions that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
- Blood Draw: You will have a blood draw three times (4.2-5 tablespoons) to determine your baseline, 1 year, and 2 year research results.
6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.
- Conditions
- Bone Tumor, Cancer of Bone, Heart Diseases, Cognitive Impairment, Cognitive Decline, Chemotherapy Effect
- Being tested
- Questionnaires, Interviews, Blood Test, Echocardiogram
- Keywords
- Endoprosthesis, Metallosis, Toxicity
- Medical subject headings
- Bone Neoplasms, Heart Diseases, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.
InterviewsBehavioural
Cognition and memory interviews will take place with the patient.
Blood TestDiagnostic test
Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.
EchocardiogramDiagnostic test
Each echocardiogram takes about 3 hours and 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images.
| Study group | Role | What they receive |
|---|---|---|
| Endoprosthesis | Patients with a endoprosthesis Receives: Behavioral: Questionnaires; Behavioral: Interviews; Diagnostic Test: Blood Test; Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echo - Left Ventricular Ejection Fraction
The echocardiogram will measure changes in LV ejection fraction as a percent.
Measured: Echo's will be taken at baseline, 1 year, and 2 years
Echo - Left Ventricular Mass
The echocardiogram will measure changes in LV Mass in grams.
Measured: Echo's will be taken at baseline, 1 year, and 2 years
Echo - Heart Hypertrophy
The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.
Measured: Echo's will be taken at baseline, 1 year, and 2 years
Cobalt Metal Levels
The change in cobalt blood ion levels will be measured in ng/mL.
Measured: Cobalt level will be measured at baseline, 1 year, and 2 years
Chromium Metal Levels
The change in chromium blood ion levels will be measured in ng/mL.
Measured: Chromium level will be measured at baseline, 1 year, and 2 years
Titanium Metal Levels
The change in titanium blood ion levels will be measured in ng/mL.
Measured: Titanium level will be measured at baseline, 1 year, and 2 years
Secondary outcomes (2)
Psychometrist Testing - Intelligence Score
The change in participants' intelligence will be measured using the Wechsler Adult Intelligence Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.
Measured: Testing will occur at baseline, 1 year, and 2 years.
Psychometrist Testing - Memory Score
The change in participants' memory will be measured using the Wechsler Adult Memory Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.
Measured: Testing will occur at baseline, 1 year, and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start19 Mar 2021
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Matthew Houdek, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755140
- Sponsor's protocol ID
- 20-008408
- Other IDs
- R01AG060920, R01HL147155-02
- Status last verified
- May 2024
- First submitted
- 28 Jan 2021
- Last updated
- 16 Dec 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis
- ClinicalTrials.gov ID
- NCT04755140
- Acronym / sponsor ID
- 20-008408
- Conditions
- Bone Tumor, Cancer of Bone, Heart Diseases, Cognitive Impairment, Cognitive Decline, Chemotherapy Effect
- Keywords
- Endoprosthesis, Metallosis, Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 15 Feb 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.
The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur.
Detailed description
At your first visit you will be asked to do the following:
- Sign the consent document.
- Patient Interview: An interview will be conducted by the study coordinator on the research team. They will ask your past surgical history, health history, medications, and your cognition.
- Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
- Memory Interview: You will be evaluated on your memory and thinking skills three total times. One to determine baseline, and then repeated at one year and two years. You will answer questions that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
- Blood Draw: You will have a blood draw three times (4.2-5 tablespoons) to determine your baseline, 1 year, and 2 year research results.
6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoprosthesis | – | Behavioral: Questionnaires, Behavioral: Interviews, Diagnostic Test: Blood Test, Diagnostic Test: EchocardiogramPatients with a endoprosthesis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients to complete cardiology part of the study (questionnaires, blood test, echocardiogram). 150 patients to complete cognitive part of the study (questionnaires, interviews, blood test). Patient groups may overlap.
Key inclusion criteria (1 listed)
- Patient has an endoprosthesis after extremity malignancy
Key exclusion criteria (2 listed)
- Current fracture or infection around the endoprosthesis
- Patient is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesThe patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities. | Behavioural | Endoprosthesis |
| InterviewsCognition and memory interviews will take place with the patient. | Behavioural | Endoprosthesis |
| Blood TestThree blood draws will occur to assess patients immune response, metal levels, and cardiac health. | Diagnostic test | Endoprosthesis |
| EchocardiogramEach echocardiogram takes about 3 hours and 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images. | Diagnostic test | Endoprosthesis |
Primary outcome
Echo - Left Ventricular Ejection Fraction
Time frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV ejection fraction as a percent.
Echo - Left Ventricular Mass
Time frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV Mass in grams.
Echo - Heart Hypertrophy
Time frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.
Cobalt Metal Levels
Time frame: Cobalt level will be measured at baseline, 1 year, and 2 years
The change in cobalt blood ion levels will be measured in ng/mL.
Chromium Metal Levels
Time frame: Chromium level will be measured at baseline, 1 year, and 2 years
The change in chromium blood ion levels will be measured in ng/mL.
Titanium Metal Levels
Time frame: Titanium level will be measured at baseline, 1 year, and 2 years
The change in titanium blood ion levels will be measured in ng/mL.
2 secondary outcomes
Psychometrist Testing - Intelligence Score
Time frame: Testing will occur at baseline, 1 year, and 2 years.
Psychometrist Testing - Memory Score
Time frame: Testing will occur at baseline, 1 year, and 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Matthew Houdek, MD principal investigator
Mayo Clinic
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 Bone Tumor and Cancer of Bone, run by Mayo Clinic 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 16 Dec 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Echo - Left Ventricular Ejection Fraction (time frame: Echo's will be taken at baseline, 1 year, and 2 years). The study lists 6 primary outcomes in all. 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 16 Dec 2024.