Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
NCT ID: NCT03665077
Last Updated: 2023-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2018-02-28
2022-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants
Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
Initial blood draw
At baseline, patients will undergo a blood draw.
Initial SWE ultrasound
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
Blood draw at three months
Blood drawn at three months to evaluate oxylipins.
Blood draw at six months
Blood drawn at six months to evaluate oxylipins.
SWE ultrasound at six months
SWE ultrasound at six months to evaluate tendon stiffness.
Interventions
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Initial blood draw
At baseline, patients will undergo a blood draw.
Initial SWE ultrasound
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
Blood draw at three months
Blood drawn at three months to evaluate oxylipins.
Blood draw at six months
Blood drawn at six months to evaluate oxylipins.
SWE ultrasound at six months
SWE ultrasound at six months to evaluate tendon stiffness.
Eligibility Criteria
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Inclusion Criteria
2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines
3. Have a histologically-confirmed diagnosis of breast cancer
4. Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
5. Age ≥ 21 years
6. Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)
7. Completed definitive therapy (surgery ± radiation)
8. Candidates for adjuvant AI therapy
Exclusion Criteria
2. Prior endocrine therapy (AI or tamoxifen)
3. History of rheumatoid arthritis or other autoimmune arthritis
4. Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
5. Current use of daily corticosteroids or immunosuppressive therapies
21 Years
FEMALE
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Pavani Chalasani
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona Cancer Center
Tucson, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Oxylipins as Biomarkers for Aromatase Inhibitor-Induced Arthralgia (AIA) in Breast Cancer Patients
Feasibility Trial to Evaluate Tendon Stiffness Obtained from Shear Wave Elastography Imaging as a Biomarker of Aromatase Inhibitor-Induced Arthralgias
Other Identifiers
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NCI-2018-00099
Identifier Type: REGISTRY
Identifier Source: secondary_id
1712078374
Identifier Type: -
Identifier Source: org_study_id
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