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Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome

NCT03665077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-08-24

Study results available
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Summary

This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.

Conditions

  • Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)
  • Breast Cancer

Interventions

DIAGNOSTIC_TEST

Initial blood draw

At baseline, patients will undergo a blood draw.

DIAGNOSTIC_TEST

Initial SWE ultrasound

At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

DIAGNOSTIC_TEST

Blood draw at three months

Blood drawn at three months to evaluate oxylipins.

DIAGNOSTIC_TEST

Blood draw at six months

Blood drawn at six months to evaluate oxylipins.

DIAGNOSTIC_TEST

SWE ultrasound at six months

SWE ultrasound at six months to evaluate tendon stiffness.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Pavani Chalasani · University of Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2022-06-15
Completion
2022-06-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03665077 on ClinicalTrials.gov