Biomarkers in Blood Samples From Older Breast Cancer Survivors
- Conditions
- Breast Cancer
- Interventions
- Genetic: gene expression analysisGenetic: reverse transcriptase-polymerase chain reactionOther: laboratory biomarker analysisOther: medical chart reviewOther: questionnaire administration
- Registration Number
- NCT01138345
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 246
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment w/Surgery gene expression analysis Breast Cancer survivors treated with surgery with or without radiation. Treatment w/Surgery reverse transcriptase-polymerase chain reaction Breast Cancer survivors treated with surgery with or without radiation. Treatment w/Surgery laboratory biomarker analysis Breast Cancer survivors treated with surgery with or without radiation. Treatment w/endocrine therapy medical chart review Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy. Treatment w/Surgery medical chart review Breast Cancer survivors treated with surgery with or without radiation. Treatment w/endocrine therapy reverse transcriptase-polymerase chain reaction Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy. Treatment w/endocrine therapy questionnaire administration Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy. Treatment w/ chemotherapy reverse transcriptase-polymerase chain reaction Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. Treatment w/ chemotherapy gene expression analysis Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. Treatment w/ chemotherapy medical chart review Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. Treatment w/ chemotherapy laboratory biomarker analysis Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. Treatment w/ chemotherapy questionnaire administration Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. Treatment w/Surgery questionnaire administration Breast Cancer survivors treated with surgery with or without radiation. Treatment w/endocrine therapy gene expression analysis Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy. Treatment w/endocrine therapy laboratory biomarker analysis Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy.
- Primary Outcome Measures
Name Time Method p16INK4a expression between cohort 1 vs cohort 2 2 years p16INK4a expression between cohort 2 vs cohort 3 2 years p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States