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| ID | Type | Description | Link |
|---|---|---|---|
| 98671 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| BRSNSTU0026 | Other Identifier | OnCore Number |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.
Patients undergoing core needle biopsy of breast abnormalities suspicious for breast cancer will be identified and enrolled in study. As well as those who have had a core needle biopsy demonstrating breast cancer, but who have not yet undergone local surgical treatment, chemotherapy, or hormonal therapy are also eligible. patients with breast cancer on core biopsy will be eligible.
Participants will be assigned to treatment (0, 2000, 4000, 6000 IU/day vitamin D by mouth) based solely on their serum vitamin D levels (Normal: >40 ng/mL; Low-normal: 31-40 ng/mL; Low: 20-30 ng/mL; Very-low: <20 ng/mL). Prior to definitive breast cancer surgery, vitamin D level, parathyroid level, and calcium will be reassessed. Samples of the patients original core biopsy and pathology specimen from their definitive surgical therapy will undergo gene expression profiling.
The ultimate plan is to correlate baseline vitamin D levels with classic prognostic and predictive markers to see if breast cancer biology is impacted by baseline vitamin D level and by vitamin D supplementation and to see if vitamin D supplementation results in gene expression changes similar to those of the vitamin D sufficient group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Vitamin D Levels | No Intervention | No additional Vitamin D administered | |
| Low-normal Vitamin D Levels | Experimental | 2000 IU dose of Vitamin D per day administered orally |
|
| Low Vitamin D Levels | Experimental | 4000 IU dose of Vitamin D per day administered orally |
|
| Very-low Vitamin D Levels | Experimental | 6000 IU dose of Vitamin D per day administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | 0, 2000, 4000, and 6000 IU per day orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer | Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes | 10 days to 4 weeks post diagnosis. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Telli, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Vitamin D Levels | No additional Vitamin D administered |
| FG001 | Low-normal Vitamin D Levels | 2000 IU dose of Vitamin D per day administered orally |
| FG002 | Low Vitamin D Levels | 4000 IU dose of Vitamin D per day administered orally |
| FG003 | Very-low Vitamin D Levels | 6000 IU dose of Vitamin D per day administered orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention (No Vitamin D) | Patients with breast cancer detected by biopsy |
| BG001 | 2000 UI Vitamin D | Patients with breast cancer detected by biopsy |
| 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 |
| 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 | Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer | Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes | Posted | Number | percentage of participants | 10 days to 4 weeks post diagnosis. |
|
3 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D Normal | No Additional Vitamin D will be given (these patients have normal Vitamin D levels). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melinda Telli | StanfordU | 650-724-9533 | steinhau@stanford.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| C055085 | calcipotriene |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 | 4000 UI Vitamin D | Patients with breast cancer detected by biopsy |
| BG003 | 6000 UI Vitamin D | Patients with breast cancer detected by biopsy |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Low Vitamin D Levels | 4000 IU dose of Vitamin D per day administered orally |
| OG003 | Very-low Vitamin D Levels | 6000 IU dose of Vitamin D per day administered orally |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Vitamin D Low-normal | 2000 IU dose of vitamin D per day (these patients have slightly low vitamin D levels). Vitamin D: 2000 IU per day orally | 0 | 19 | 0 | 19 |
| EG002 | Vitamin D Low | 4000 IU dose of vitamin D per day (these patients have low vitamin D levels). Vitamin D: 4000 IU per day orally | 0 | 11 | 0 | 11 |
| EG003 | Vitamin D Very Low | 6000 IU dose of vitamin D per day (these patients have very low vitamin D levels). Vitamin D: 6000 IU per day orally | 0 | 4 | 0 | 4 |
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| D017437 |
| Skin and Connective Tissue Diseases |