AzTrials
AzTrials

Breast CancerNCT00373191

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

An observational study of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
chemotherapy, endocrine therapy and DNA methylation analysis
Type of treatment
Surgery or procedure
How many people
35 participants
Where
1 siteUnited States
Study dates
May 2006to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with newly diagnosed ductal carcinoma in situ or invastive breast cancer.

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: 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.

Read the 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 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.

Conditions
Breast Cancer
Being tested
chemotherapy, endocrine therapy, DNA methylation analysis, protein analysis, laboratory biomarker analysis
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, ductal breast carcinoma in situ
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapyDrug

    N/A- not dictated by study

  • endocrine therapyDrug

    N/A- not dictated by study

  • DNA methylation analysisGenetic

    laboratory analysis

  • protein analysisGenetic

    laboratory analysis

  • laboratory biomarker analysisOther

    laboratory analysis

  • questionnaire administrationOther

    questionnaire

  • adjuvant therapyProcedure or surgery

    N/A- not dictated by study

  • conventional surgeryProcedure or surgery

    N/A- not dictated by study

  • radiation therapyRadiation

    N/A- not dictated by study

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: indefinite

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionFeb 2009
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00373191
Sponsor's protocol ID
J0575 CDR0000485360
Other IDs
P30CA006973, JHOC-J0575, JHOC-SKCCC-J0575
Status last verified
Oct 2015
First submitted
6 Sep 2006
Last updated
12 Oct 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in high-sensitivity C-reactive protein and gene methylation over time (time frame: indefinite). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00373191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in