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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03535 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Funding
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This study investigates the impact of breast cancer treatment on joint health, cartilage, composition, and bone structure in the knee and hand in patients with hormone-receptor positive stage I-III breast cancer and healthy patients. The investigators will use Magnetic Resonance Imaging (MRI) to assess the quality of hand and knee joints. This study may help doctors learn more about hand and knee joint pain that occurs during aromatase inhibitor treatment.
PRIMARY OBJECTIVE:
I. To investigate pathological alterations in cartilage and joints in breast cancer patients on aromatase inhibitor (AI)s with and without pain and in healthy control patients.
OUTLINE:
Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI of about 60 minutes.
After completion of study, a subset of patients are followed up at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (questionnaires, MRI) | Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI over 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean differences in hyaline cartilage biochemical composition | Will determine differences in hyaline cartilage biochemical composition (using magnetic resonance imaging) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors). | Up to 6 months |
| Differences in morphological joint abnormalities | Will determine differences in morphological joint abnormalities (using semi-quantitative magnetic resonance-based scores) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors). | Up to 6 months |
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Inclusion Criteria:
Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
Breast cancer patients with either natural or chemically induced menopause with stage 1-3 hormone receptor-positive breast cancers and on AI for at least one year OR healthy postmenopausal women
Breast cancer patients on aromatase inhibitors (AI) may fall into one of the three following groups:
Age <= 70 years old
Ability to read and complete quality of life surveys in English (or have a family member or friend available to translate and assist in completing surveys)
Exclusion Criteria:
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Patients with a diagnosis of breast cancer and normal controls.
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| Name | Affiliation | Role |
|---|---|---|
| Roland Krug, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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| Questionnaire Administration | Other | Complete questionnaires |
|
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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