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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
  Purpose

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 Intervention
Breast Cancer
 Other: Healthy Controls
Other: Metastatic Breast Cancer
Other: Non-cancer medical illness

Study Type: Observational
Official Title: Serum Glycan Analysis in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Predictability of serial serum biomarkers in determining disease response and/or progression [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2006
Estimated Study Completion Date: January 2014
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897962

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00897962     History of Changes
Other Study ID Numbers: CDR0000583066, UCD-186, UCD-200614601
Study First Received: May 9, 2009
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013