Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

Breast Cancer Clinical Trial

Official title:

Serum Glycan Analysis in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897962
• Other study ID #: 234870
• Secondary ID: UCD-186UCD-20061
• Status: Completed
• Start date: September 2006
• Est. completion date: January 12, 2016

Study information

• Verified date: December 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: January 12, 2016
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Healthy Controls
One blood draw (2 teaspoons)
• Metastatic Breast Cancer
Blood samples will be drawn every 3 months, for up to 18 months.
• Non-cancer medical illness
One blood draw (2 teaspoons)

Locations

Country	Name	City	State
United States	University of California Davis Cancer Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness		up to 18 months
Secondary	Predictability of serial serum biomarkers in determining disease response and/or progression		Up to 18 months