Clinical trial NCT04755140: Endoprosthesis Metal Toxicity Study
Official title: Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Tumor
Cancer of Bone
Heart Diseases
Cognitive Impairment
Cognitive Decline
Chemotherapy Effect
Memory Problem
Keywords: Endoprosthesis
Metallosis
Toxicity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Aging (NIA)
First posted: 2021-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

Detailed description: At your first visit you will be asked to do the following:

1. Sign the consent document.
2. 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.
3. Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
4. 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.
5. 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.

Eligibility criteria: Inclusion Criteria:

* Patient has an endoprosthesis after extremity malignancy

Exclusion Criteria:

* Current fracture or infection around the endoprosthesis
* Patient is pregnant

Primary outcomes:
measure: Echo - Left Ventricular Ejection Fraction
timeFrame: Echo's will be taken at baseline, 1 year, and 2 years
measure: Echo - Left Ventricular Mass
timeFrame: Echo's will be taken at baseline, 1 year, and 2 years
measure: Echo - Heart Hypertrophy
timeFrame: Echo's will be taken at baseline, 1 year, and 2 years
measure: Cobalt Metal Levels
timeFrame: Cobalt level will be measured at baseline, 1 year, and 2 years
measure: Chromium Metal Levels
timeFrame: Chromium level will be measured at baseline, 1 year, and 2 years
measure: Titanium Metal Levels
timeFrame: Titanium level will be measured at baseline, 1 year, and 2 years
Secondary outcomes:
measure: Psychometrist Testing - Intelligence Score
timeFrame: Testing will occur at baseline, 1 year, and 2 years.
measure: Psychometrist Testing - Memory Score
timeFrame: Testing will occur at baseline, 1 year, and 2 years.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Houdek, MD
role: PRINCIPAL_INVESTIGATOR
References: