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Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00897962
First received: May 9, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes

May 9, 2009
February 4, 2013
September 2006
February 2011   (final data collection date for primary outcome measure)
Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897962 on ClinicalTrials.gov Archive Site
Predictability of serial serum biomarkers in determining disease response and/or progression [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
Predictability of serial serum biomarkers in determining disease response and/or progression [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Blood Glycan Biomarkers in Women With Stage IV Breast Cancer
Serum Glycan Analysis in Breast Cancer

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV breast cancer.

OBJECTIVES:

  • To profile serum glycan biomarkers in women with metastatic stage IV breast cancer, healthy controls, and patients with noncancer medical illness.
  • To determine whether serial serum glycan biomarkers correlate with response of metastatic disease to treatment.

OUTLINE: This is a multicenter study.

Blood is collected from patients with metastatic breast cancer, patients with noncancerous illness, and healthy volunteers. Samples are analyzed for serum glycan biomarkers by matrix-assisted laser desorption/ionization (MALDI) and Fourier transform ion-cyclotron resonance mass spectrometry (FT ICR MS) methods.

Blood samples are collected every 3 months for up to 18 months from patients with metastatic breast cancer. Patients without cancer have a single sample collected.
Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample

Patients with metastatic breast cancer receiving active chemotherapy, endocrine therapy or targeted therapy Healthy age matched controls without chronic diseases and not on regular prescription medications Patients seen at Internal Medicine Clinic for any reason other than active, metastatic cancer
Breast Cancer
  • Other: Healthy Controls
    One blood draw (2 teaspoons)
  • Other: Metastatic Breast Cancer
    Blood samples will be drawn every 3 months, for up to 18 months.
  • Other: Non-cancer medical illness
    One blood draw (2 teaspoons)
  • Metastatic Breast Cancer
    Patients with metastatic breast cancer receiving treatment with chemotherapy, endocrine therapy or targeted therapy
    Intervention: Other: Metastatic Breast Cancer
  • Non-cancer medical illness
    Patients with non-cancer medical condition
    Intervention: Other: Non-cancer medical illness
  • Healthy Controls
    Healthy patients being seen for an annual exam
    Intervention: Other: Healthy Controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2014
February 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Patient or participant at the Women's Health Clinic, the Internal Medicine Clinic, or at the UC Davis Cancer Center, meeting 1 of the following criteria:

    • Diagnosis of stage IV metastatic breast cancer, receiving active treatment with chemotherapy, endocrine therapy, or targeted therapy

    • Patients/participants without cancer

      • Healthy control being seen for annual exams, meeting the following criteria:

        • No chronic disease
        • Not on regular prescribed medications
      • Patient without cancer being seen in the Internal Medicine Clinic
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Not pregnant or breast feeding
  • No other active cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897962
CDR0000583066, UCD-186, UCD-200614601
Yes
University of California, Davis
University of California, Davis
Not Provided
Study Chair: Helen K. Chew, MD University of California, Davis
University of California, Davis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP