Bone Tumor, Cancer of Bone, Chemotherapy Effect, Cognitive Decline, Cognitive Impairment, Heart Diseases, Memory Problem
Conditions
Keywords
Endoprosthesis, Metallosis, Toxicity
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.
Interventions
BEHAVIORALQuestionnaires
The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.
BEHAVIORALInterviews
Cognition and memory interviews will take place with the patient.
DIAGNOSTIC_TESTBlood Test
Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.
DIAGNOSTIC_TESTEchocardiogram
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.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient has an endoprosthesis after extremity malignancy
Exclusion criteria
* Current fracture or infection around the endoprosthesis * Patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titanium Metal Levels | 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. |
| Cobalt Metal Levels | 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 | 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. |
| Echo - Left Ventricular Ejection Fraction | 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 | 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 | Echo's will be taken at baseline, 1 year, and 2 years | The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychometrist Testing - Memory Score | Testing will occur at baseline, 1 year, and 2 years. | 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. |
| Psychometrist Testing - Intelligence Score | Testing will occur at baseline, 1 year, and 2 years. | 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. |
Countries
United States
Outcome results
None listed