Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
- Measure the effects of surgery and radiation on concentrations of high-sensitivity
C-reactive protein (hsCRP) in women with newly diagnosed stage I-III invasive breast
cancer or ductal carcinoma in situ.
- Measure the effects of chemotherapy and/or endocrine therapy on concentrations of hsCRP
in these patients.
- Summarize the differences in preoperative to peri-chemotherapy hsCRP concentrations
separately for patients who do and who do not receive growth factors during
- Observe the change in hsCRP concentrations and gene methylation over time with local
and systemic treatment in these patients.
- Explore prevalence of baseline and change in methylation in a panel of genes that is
known to be frequently and specifically hypermethylated in breast cancer.
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.
Observational Model: Cohort, Time Perspective: Prospective
Change in high-sensitivity C-reactive protein and gene methylation over time
Vered Stearns, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|