Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA036727 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at urine samples from women with newly diagnosed breast cancer.
OBJECTIVES:
OUTLINE: Previously collected urine samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultra-performance liquid chromatography with tandem mass spectrometric detection.
Patient information (e.g., race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption) is collected through medical record review.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high performance liquid chromatography | Other | Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry. | ||
| laboratory biomarker analysis | Other | The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts. | ||
| mass spectrometry | Other | Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry. | ||
| medical chart review | Other | Information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease, body mass index, age at menarche, menopausal status (pre- or peri- menopausal or postmenopausal), age at menopause if applicable, chemotherapy regimen (if applicable), radiation therapy (if applicable), smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy and disease type. |
| Measure | Description | Time Frame |
|---|---|---|
| Estrogen compounds | Estrogen compounds in urine | at baseline at 6 months and annually |
Not provided
Not provided
Inclusion Criteria:
Newly diagnosed ductal carcinoma in situ or invasive breast cancer
Urine biospecimens available from participation in protocol UNMC-08105 (IRB#311-06), the Breast Cancer Collaborative Registry (BCCR), which included treatment with tamoxifen or an aromatase inhibitor
o Urine specimens were collected at baseline, 6 months, and then annually
Estrogen receptor or progesterone receptor positive
ECOG performance status 0-2
Exclusion Criteria:
Not provided
Not provided
Not provided
Women with breast cancer
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ercole Cavalieri, DSc | Eppley Cancer Center, University of Nebraska Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eppley Cancer Center, University of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | United States |
Not provided
Not provided
Not provided
Not provided
Urine
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
Not provided
Not provided
| ID | Term |
|---|---|
| D002851 | Chromatography, High Pressure Liquid |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided