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Completed

NCT Number: NCT00373191

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically and/or cytologically confirmed stage I-III invasive breast carcinoma or ductal carcinoma in situ
  • Newly diagnosed disease
  • Patient must be initiating a new course of treatment for breast carcinoma, including surgery (mastectomy or lumpectomy with or without nodal evaluation) with or without any of the following:
  • Radiation therapy
  • Chemotherapy
  • Endocrine therapy
  • No known or suspected metastatic disease
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • No infectious or inflammatory condition, at the discretion of the principal investigator
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior surgery
  • Fine-needle aspirate or biopsy allowed
  • More than 6 months since prior radiotherapy
  • More than 6 months since prior chemotherapy
  • More than 6 months since prior endocrine therapy
  • No neoadjuvant endocrine therapy or chemotherapy
  • More than 2 weeks since prior and no concurrent regular use of any of the following:
  • Hydroxymethyl glutaryl coenzyme A reductase inhibitor (statin)
  • Nonsteroidal anti-inflammatory drug (NSAID)*
  • Cyclooxygenase-2 (COX-2) inhibitor
  • Aspirin*
  • Acetaminophen and opioid use is permitted as needed NOTE: *Use of these products ≤ 2 times per week at standard over-the-counter doses allowed

Treatment and study plan

Chemotherapy

Drug

N/A- not dictated by study

endocrine therapy

Drug

N/A- not dictated by study

DNA methylation analysis

Genetic

laboratory analysis

protein analysis

Genetic

laboratory analysis

laboratory biomarker analysis

Other

laboratory analysis

Questionnaire Administration

Other

questionnaire

adjuvant therapy

Procedure

N/A- not dictated by study

conventional surgery

Procedure

N/A- not dictated by study

radiation therapy

Radiation

N/A- not dictated by study

Primary outcomes

  1. Change in high-sensitivity C-reactive protein and gene methylation over time

    Time frame: indefinite

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer

Important dates

Study start
2006
Primary completion
2009
Study completion
2013
First posted
Sep 7, 2006
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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