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OpenTrials
Completed

NCT Number: NCT00897962

Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy controls

Other

One blood draw (2 teaspoons)

Metastatic Breast Cancer

Other

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

Non-cancer medical illness

Other

One blood draw (2 teaspoons)

Primary outcomes

  1. 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

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

    Time frame: Up to 18 months

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Serum Glycan Analysis in Breast Cancer

Important dates

Study start
2006
Primary completion
2011
Study completion
2016
First posted
May 12, 2009
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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