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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA058185 | U.S. NIH Grant/Contract | View source | |
| P30CA051008 | U.S. NIH Grant/Contract | View source | |
| GUMC-99225 |
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Funding ended
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of breast tissue in the laboratory may help doctors learn more about the genes and proteins found in breast tissue.
PURPOSE: This phase I trial is studying genes and proteins in breast tissue from women undergoing surgery for breast cancer or core biopsy of the breast.
OBJECTIVES:
OUTLINE: This is a pilot study.
Tumor tissue is collected and analyzed for tumor gene expression by DNA microarray analysis for research studies.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microarray analysis | Genetic | tumor specimen will be assessed by microarray analysis | ||
| breast biopsy | Procedure | A breast biopsy will be done to obtain a tumor specimen |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Gene Expression as Assessed by RNA Microarray Analysis | Concentration of RNA recovered from breast needle biopsies | 1 day |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Any woman undergoing a breast biopsy or breast surgery
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| Name | Affiliation | Role |
|---|---|---|
| Claudine Isaacs, MD | Lombardi Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Snap-frozen | Method of RNA recovery: Snap-frozen For more information about snap-frozen RNA recovery please see this link: |
| FG001 | RNALater | Method of RNA recovery: RNALater For more information on RNAlater please see this link: https://www.thermofisher.com/us/en/home/brands/product-brand/rnalater.html |
| FG002 | Method of RNA recovery: unknown |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Snap-frozen | Method of RNA recovery: Snap-frozen |
| BG001 | RNALater | Method of RNA recovery: RNALater |
| 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 | Tumor Gene Expression as Assessed by RNA Microarray Analysis | Concentration of RNA recovered from breast needle biopsies | Posted | Mean | Standard Error | micrograms | 1 day |
|
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Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Snap-frozen | Method of RNA recovery: Snap-frozen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudine Isaacs | Georgetown University Medical Center - Lombardi Comprehensive Cancer Center | 202-444-3677 | isaacsc@georgetown.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 |
|---|---|
| D046228 | Microarray Analysis |
| ID | Term |
|---|---|
| D046208 | Microchip Analytical Procedures |
| D008919 | Investigative Techniques |
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| BG002 |
| Unknown |
Method of RNA recovery: unknown |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | RNALater | Method of RNA recovery: RNALater | 0 | 0 | 0 | 0 |
| EG002 | Method of RNA recovery: unknown | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|