Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Other: Healthy Controls; Other: Metastatic Breast Cancer; Other: Non-cancer medical illness

• Registration Number: NCT00897962
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2011-02
• Study Completion: 2016-01-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 163

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Healthy Controls	Healthy patients being seen for an annual exam
Metastatic Breast Cancer	Metastatic Breast Cancer	Patients with metastatic breast cancer receiving treatment with chemotherapy, endocrine therapy or targeted therapy
Non-cancer medical illness	Non-cancer medical illness	Patients with non-cancer medical condition

Primary Outcome Measures

Name	Time	Method
Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness	up to 18 months

Secondary Outcome Measures

Name	Time	Method
Predictability of serial serum biomarkers in determining disease response and/or progression	Up to 18 months

Trial Locations

Locations (1)

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States