Trials / Completed
CompletedNCT03665077
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
Detailed description
This is a prospective single arm study enrolling patients (n = 25) with breast cancer scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE) ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths. This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is analyzed, goal is to apply for funding for a larger trial to further evaluate and validate these biomarkers
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-02-28
- Primary completion
- 2022-06-15
- Completion
- 2022-06-15
- First posted
- 2018-09-11
- Last updated
- 2023-08-24
- Results posted
- 2023-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03665077. Inclusion in this directory is not an endorsement.