Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00897962
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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.

Condition or disease Intervention/treatment
Breast Cancer Other: Healthy Controls Other: Metastatic Breast Cancer Other: Non-cancer medical illness

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Serum Glycan Analysis in Breast Cancer
Study Start Date : September 2006
Actual Primary Completion Date : February 2011
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Metastatic Breast Cancer
Patients with metastatic breast cancer receiving treatment with chemotherapy, endocrine therapy or targeted therapy
Other: Metastatic Breast Cancer
Blood samples will be drawn every 3 months, for up to 18 months.

Non-cancer medical illness
Patients with non-cancer medical condition
Other: Non-cancer medical illness
One blood draw (2 teaspoons)

Healthy Controls
Healthy patients being seen for an annual exam
Other: Healthy Controls
One blood draw (2 teaspoons)

Primary Outcome Measures :
  1. Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness [ Time Frame: up to 18 months ]

Secondary Outcome Measures :
  1. Predictability of serial serum biomarkers in determining disease response and/or progression [ Time Frame: Up to 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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


  • 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


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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00897962

United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Study Chair: Helen K. Chew, MD University of California, Davis

Responsible Party: University of California, Davis Identifier: NCT00897962     History of Changes
Other Study ID Numbers: 234870
CDR0000583066 ( Other Identifier: UC Davis )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by University of California, Davis:
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases