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
|First Received Date ICMJE||September 6, 2006|
|Last Updated Date||October 2, 2012|
|Start Date ICMJE||May 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in high-sensitivity C-reactive protein and gene methylation over time [ Time Frame: indefinite ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00373191 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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|
|Official Title ICMJE||Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer|
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.
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
|Sampling Method||Probability Sample|
Patients with newly diagnosed ductal carcinoma in situ or invastive breast cancer.
|Condition ICMJE||Breast Cancer|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||30|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00373191|
|Other Study ID Numbers ICMJE||J0575 CDR0000485360, P30CA006973, JHOC-J0575, JHOC-SKCCC-J0575|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Sidney Kimmel Comprehensive Cancer Center|
|Study Sponsor ICMJE||Sidney Kimmel Comprehensive Cancer Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||Sidney Kimmel Comprehensive Cancer Center|
|Verification Date||October 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP