Biomarkers in Blood Samples From Older Breast Cancer Survivors
NCT ID: NCT01138345
Last Updated: 2014-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
246 participants
OBSERVATIONAL
2010-01-31
2014-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Treatment w/Surgery
Breast Cancer survivors treated with surgery with or without radiation.
gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
medical chart review
perform medical chart review for all subjects
questionnaire administration
each cohort will be given the same questionnaire
Treatment w/endocrine therapy
Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy.
gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
medical chart review
perform medical chart review for all subjects
questionnaire administration
each cohort will be given the same questionnaire
Treatment w/ chemotherapy
Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy.
gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
medical chart review
perform medical chart review for all subjects
questionnaire administration
each cohort will be given the same questionnaire
Interventions
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gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
medical chart review
perform medical chart review for all subjects
questionnaire administration
each cohort will be given the same questionnaire
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Hyman Muss, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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CDR0000674103
Identifier Type: OTHER
Identifier Source: secondary_id
LCCC 0924
Identifier Type: -
Identifier Source: org_study_id
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