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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016086 | U.S. NIH Grant/Contract | View source | |
| CDR0000674103 | Other Identifier | PDQ number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers in blood samples from older women with stage I, stage II, or stage III breast cancer who have finished primary therapy or breast cancer survivors.
OBJECTIVES:
Primary
Secondary
Tertiary (exploratory)
OUTLINE: Breast cancer survivors and healthy volunteers undergo blood collection for p16^INK4a gene expression analysis by Taqman RT-PCR.
Breast cancer survivors complete the Health Behavior and the Geriatric Assessment Questionnaires. They also complete a Timed Up and Go test to determine physical mobility.
Medical charts are reviewed to record information about diagnosis and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment w/Surgery | Breast Cancer survivors treated with surgery with or without radiation. |
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| Treatment w/endocrine therapy | Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy. |
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| Treatment w/ chemotherapy | Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | blood samples will be analyzed for the expression of the p16 gene. |
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| Measure | Description | Time Frame |
|---|---|---|
| p16INK4a expression between cohort 2 vs cohort 3 | 2 years | |
| p16INK4a expression between cohort 1 vs cohort 2 | 2 years | |
| p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4 | 2 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Breast cancer survivors meeting 1 of the following criteria:
Prior surgery with or without (±) radiotherapy (RT) (cohort 1)
Prior surgery ± RT, followed by prior or concurrent hormonal (endocrine) therapy (cohort 2)
Prior surgery ± RT, followed by prior chemotherapy ± endocrine therapy (cohort 3)
No recurrent disease
No history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Breast cancer survivors age 50 and older who have completed their breast cancer treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Hyman Muss, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
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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 |
|---|---|
| D020869 | Gene Expression Profiling |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
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blood samples
| reverse transcriptase-polymerase chain reaction | Genetic | perform reverse transcriptase-polymerase chain reaction on all blood samples. |
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| laboratory biomarker analysis | Other | perform laboratory biomarker analysis on all blood samples |
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| medical chart review | Other | perform medical chart review for all subjects |
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| questionnaire administration | Other | each cohort will be given the same questionnaire |
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| D017437 |
| Skin and Connective Tissue Diseases |