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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| JHOC-J0575 | Other Identifier | SKCCC | |
| JHOC-SKCCC-J0575 | Other Identifier | SKCCC |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at the effects of surgery, radiation therapy, chemotherapy, and hormone therapy on biomarkers in women with stage I, stage II, stage III breast cancer, or ductal carcinoma in situ that can be removed by surgery.
OBJECTIVES:
OUTLINE: This is a prospective study.
A blood sample is collected at baseline, approximately 1 week after surgery, and at the time of a routine follow-up visit 3-6 months after completion of all local and systemic therapy, except for patients receiving endocrine therapy. For patients receiving adjuvant chemotherapy, a blood sample is collected prior to beginning chemotherapy and once during the final 2 courses of chemotherapy. For patients receiving radiotherapy, a blood sample is collected during the final 2 weeks of radiotherapy. For patients receiving endocrine therapy, a blood sample is collected between 2 and 6 months after starting endocrine therapy. Patients also complete a questionnaire about overall health and concurrent medications at baseline and during each follow-up visit.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy | Drug | N/A- not dictated by study | ||
| endocrine therapy | Drug | N/A- not dictated by study | ||
| DNA methylation analysis | Genetic | laboratory analysis | ||
| protein analysis | Genetic | laboratory analysis | ||
| laboratory biomarker analysis | Other | laboratory analysis | ||
| questionnaire administration | Other | questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Change in high-sensitivity C-reactive protein and gene methylation over time | indefinite |
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DISEASE CHARACTERISTICS:
Histologically and/or cytologically confirmed stage I-III invasive breast carcinoma or ductal carcinoma in situ
Patient must be initiating a new course of treatment for breast carcinoma, including surgery (mastectomy or lumpectomy with or without nodal evaluation) with or without any of the following:
No known or suspected metastatic disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 6 months since prior surgery
More than 6 months since prior radiotherapy
More than 6 months since prior chemotherapy
More than 6 months since prior endocrine therapy
No neoadjuvant endocrine therapy or chemotherapy
More than 2 weeks since prior and no concurrent regular use of any of the following:
Acetaminophen and opioid use is permitted as needed NOTE: *Use of these products ≤ 2 times per week at standard over-the-counter doses allowed
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Patients with newly diagnosed ductal carcinoma in situ or invastive breast cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Vered Stearns, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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Serum
| adjuvant therapy | Procedure | N/A- not dictated by study |
| conventional surgery | Procedure | N/A- not dictated by study |
| radiation therapy | Radiation | N/A- not dictated by study |
| 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 |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D019175 | DNA Methylation |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008745 | Methylation |
| D000478 | Alkylation |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D055614 | Genetic Phenomena |
| D003131 | Combined Modality Therapy |
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