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Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

Serum Glycan Analysis in Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897962
Enrollment
163
Registered
2009-05-12
Start date
2006-09-30
Completion date
2016-01-12
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer

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.

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.

Interventions

OTHERHealthy Controls

One blood draw (2 teaspoons)

OTHERMetastatic Breast Cancer

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

OTHERNon-cancer medical illness

One blood draw (2 teaspoons)

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illnessup to 18 months

Secondary

MeasureTime frame
Predictability of serial serum biomarkers in determining disease response and/or progressionUp to 18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026