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Chapel Hill, North Carolina 27599


Purpose:

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.


Study summary:

OBJECTIVES: Primary - To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy followed by endocrine therapy (cohort 2) versus surgery with or without radiotherapy followed by chemotherapy and with or without endocrine therapy (cohort 3) . - To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy (cohort 1) versus women treated in cohort 2. - To compare normalized p16^INK4a gene expression between cohorts 1, 2, and 3 versus an age-matched contemporaneous control group of healthy volunteers accrued from a separate study (cohort 4). Secondary - To access functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, nutritional status, and health-behavior status of these patients. Tertiary (exploratory) - To compare methodologies of p16 ^INK4a gene expression measurement in 50 patients in order to develop a batchable and analytically validated assay that eliminates the need for rapid sample processing. - To explore any association between p16^INK4a expression and amount of vigorous physical activity, smoking habits, and/or weekly alcohol consumption. - To explore any association between p16^INK4a expression and type of chemotherapy received, co-morbidities, concomitant medications, and/or tumor characteristics. - To correlate p16^INK4a expression with scores from selected domains of the Geriatric Assessment (i.e., cognitive function, activities of daily living (ADL), and the instrumental ADL. 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Stage I-III disease - 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) - Must have received or be on endocrine therapy for ≥ 3 months - 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: - Life expectancy > 12 months - Absolute lymphocyte count > 500/μL - No acute or active infection - No other co-morbid illness that would impair ability to participate in the study PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 3 months since prior surgery with or without radiotherapy - At least 3 months since prior chemotherapy (cohort 3) - No concurrent radiotherapy, chemotherapy, or experimental therapy


NCT ID:

NCT01138345


Primary Contact:

Principal Investigator
Hyman Muss, MD
UNC Lineberger Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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