Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373191
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2006-09-06
Brief Title:
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
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Effects of Surgery Radiation Therapy Chemotherapy and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-SKCCC-J0575 | OTHER | SKCCC | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J0575 | OTHER | None | None |