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Endoprosthesis Metal Toxicity Study

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Mayo Clinic

Status

Completed

Conditions

Chemotherapy Effect
Cognitive Impairment
Cognitive Decline
Cancer of Bone
Bone Tumor
Memory Problem
Heart Diseases

Treatments

Behavioral: Interviews
Diagnostic Test: Echocardiogram
Behavioral: Questionnaires
Diagnostic Test: Blood Test

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04755140
R01HL147155-02 (U.S. NIH Grant/Contract)
20-008408
R01AG060920 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patient has an endoprosthesis after extremity malignancy

Exclusion criteria

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

Trial design

20 participants in 1 patient group

Endoprosthesis
Description:
Patients with a endoprosthesis
Treatment:
Diagnostic Test: Blood Test
Behavioral: Questionnaires
Diagnostic Test: Echocardiogram
Behavioral: Interviews

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Peter C Brennan

Data sourced from clinicaltrials.gov

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