Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00099 | Registry Identifier | NCI Trial Identifier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Experimental | Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial blood draw | Diagnostic Test | At baseline, patients will undergo a blood draw. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oxylipin Levels | Change Oxylipin levels at Baseline, Three and Six Months | Baseline, Three months, and Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Tendon Stiffness | Tendon stiffness at baseline | Baseline |
| Pain Levels | Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Post-menopausal women
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pavani Chalasani | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
Not provided
| Label | URL |
|---|---|
| Oxylipins as Biomarkers for Aromatase Inhibitor-Induced Arthralgia (AIA) in Breast Cancer Patients | View source |
| Feasibility Trial to Evaluate Tendon Stiffness Obtained from Shear Wave Elastography Imaging as a Biomarker of Aromatase Inhibitor-Induced Arthralgias | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single arm observational study
Postmenopausal women with early-stage breast cancer prior to starting adjuvant endocrine therapy with aromatase inhibitors
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Initial SWE ultrasound |
| Diagnostic Test |
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. |
|
| Blood draw at three months | Diagnostic Test | Blood drawn at three months to evaluate oxylipins. |
|
| Blood draw at six months | Diagnostic Test | Blood drawn at six months to evaluate oxylipins. |
|
| SWE ultrasound at six months | Diagnostic Test | SWE ultrasound at six months to evaluate tendon stiffness. |
|
| Baseline, Six months |
| 3 Months Blood Draw |
|
| 6 Months Blood Draw |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Stage of Cancer | Staging is based on the patients' surgical pathology report. American Joint Committee on Cancer (AJCC) 7th staging criteria for breast cancer was used for this study. Overall 7th Edition AJCC stage (IIV) is based on the TNM classification. The lower the number, the lower the cancer stage and the better the prognosis for the patient. The higher the stage, the worse the prognosis. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxylipin Levels | Change Oxylipin levels at Baseline, Three and Six Months | Posted | Mean | Standard Deviation | pg/mL | Baseline, Three months, and Six months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tendon Stiffness | Tendon stiffness at baseline | Patients with breast cancer on adjuvant aromatase inhibitor. | Posted | Mean | Standard Deviation | m/s | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pain Levels | Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20. | Patients with early stage breast cancer on adjuvant aromatase inhibitor. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Six months |
|
|
Through study completion, an average of 6 months.
This is a pilot trial to evaluate oxylipins as blood biomarkers of aromatase inhibitor induced musculoskeletal syndrome. Adverse events were monitored for blood draws and analysis of oxylipins only. Anastrozole treatment was done as standard of care, and thus, side effects from anastrozole were managed per patients' standard of care and were not recorded for the purposes of this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 28 | 0 | 28 | 0 | 28 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pavani Chalasani | George Washington Cancer Center | (202)-741-2277 | pavani.chalasani@email.gwu.edu |
| Apr 11, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2021 | Apr 11, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stage 2 |
|
| Title | Measurements |
|---|---|
|
|
|
|
|