Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
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|ClinicalTrials.gov Identifier: NCT03665077|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment|
|Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS) Breast Cancer||Diagnostic Test: Initial blood draw Diagnostic Test: Initial SWE ultrasound Diagnostic Test: Blood draw at three months Diagnostic Test: Blood draw at six months Diagnostic Test: SWE ultrasound at six months|
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome|
|Actual Study Start Date :||February 28, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||July 1, 2020|
Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
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.
- Oxylipin levels [ Time Frame: Six months ]Compare baseline oxylipin levels in women that do vs. those that do not develop AIMSS.
- Tendon Stiffness [ Time Frame: Six months ]Compare baseline tendon stiffness measured using shear wave elastography (SWE) ultrasound in women that do vs. those that do not develop AIMSS.
- Oxylipin Correlation to Tendon Stiffness [ Time Frame: Six months ]Correlate changes in oxylipin panels with changes in tendon stiffness.
- Oxylipin/Tendon Stiffness Correlation to Pain Levels [ Time Frame: Six months ]Correlate changes in levels of oxylipins and tendon stiffness with changes in pain scores through 6-month AI treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665077
|Contact: Pavani Chalasani, MD||(520) firstname.lastname@example.org|
|Contact: Dana Lewallen||(520) email@example.com|
|United States, Arizona|
|University of Arizona Cancer Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Amy Selegue, BA, BSN, RN 520-626-0301 firstname.lastname@example.org|
|Principal Investigator: Pavani Chalasani, MD|
|Principal Investigator:||Pavani Chalasani||University of Arizona|