Effect of Surgery, Radiation Therapy, Chemotherapy, and Hormone Therapy on Biomarkers in Women With Stage I, Stage II, Stage III Breast Cancer, or Ductal Carcinoma In Situ That Can Be Removed By Surgery
|ClinicalTrials.gov Identifier: NCT00373191|
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : October 12, 2015
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at the effects of surgery, radiation therapy, chemotherapy, and hormone therapy on biomarkers in women with stage I, stage II, stage III breast cancer, or ductal carcinoma in situ that can be removed by surgery.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: chemotherapy Drug: endocrine therapy Genetic: DNA methylation analysis Genetic: protein analysis Other: laboratory biomarker analysis Other: questionnaire administration Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy|
- 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 chemotherapy.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||December 2013|
- Change in high-sensitivity C-reactive protein and gene methylation over time [ Time Frame: indefinite ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373191
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||Vered Stearns, MD||Sidney Kimmel Comprehensive Cancer Center|