Endoprosthesis Metal Toxicity Study

NCT ID: NCT04755140

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-19

Study Completion Date

2024-05-01

Brief Summary

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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

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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.

Conditions

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

Keywords

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Endoprosthesis Metallosis Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endoprosthesis

Patients with a endoprosthesis

Questionnaires

Intervention Type BEHAVIORAL

The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.

Interviews

Intervention Type BEHAVIORAL

Cognition and memory interviews will take place with the patient.

Blood Test

Intervention Type DIAGNOSTIC_TEST

Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.

Echocardiogram

Intervention Type DIAGNOSTIC_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.

Interventions

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Questionnaires

The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.

Intervention Type BEHAVIORAL

Interviews

Cognition and memory interviews will take place with the patient.

Intervention Type BEHAVIORAL

Blood Test

Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.

Intervention Type DIAGNOSTIC_TEST

Echocardiogram

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient has an endoprosthesis after extremity malignancy

Exclusion Criteria

* Current fracture or infection around the endoprosthesis
* Patient is pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Houdek, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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R01AG060920

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL147155-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-008408

Identifier Type: -

Identifier Source: org_study_id