Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

University of California, Davis163 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

163

Conditions

Breast Cancer

Interventions

Healthy ControlsOTHER

One blood draw (2 teaspoons)

Metastatic Breast CancerOTHER

Blood samples will be drawn every 3 months, for up to 18 months.

Non-cancer medical illnessOTHER

One blood draw (2 teaspoons)

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California Davis Cancer Center

Sacramento, California, United States

Outcomes

Primary Outcomes

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 Outcomes

Predictability of serial serum biomarkers in determining disease response and/or progression

Time frame: Up to 18 months

Data from ClinicalTrials.gov

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