Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

NCT00897962 | Completed DMC

• 4 other identifiers: 234870UCD-186UCD-200614601CDR0000583066
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness

  up to 18 months

Secondary Outcomes (1)

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

  Up to 18 months

Study Arms (3)

Metastatic Breast Cancer

Patients with metastatic breast cancer receiving treatment with chemotherapy, endocrine therapy or targeted therapy

Other: Metastatic Breast Cancer

Non-cancer medical illness

Patients with non-cancer medical condition

Other: Non-cancer medical illness

Healthy Controls

Healthy patients being seen for an annual exam

Other: Healthy Controls

Interventions

Healthy Controls OTHER

One blood draw (2 teaspoons)

Healthy Controls

Metastatic Breast Cancer OTHER

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

Metastatic Breast Cancer

Non-cancer medical illness OTHER

One blood draw (2 teaspoons)

Non-cancer medical illness

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic breast cancer receiving active chemotherapy, endocrine therapy or targeted therapy Healthy age matched controls without chronic diseases and not on regular prescription medications Patients seen at Internal Medicine Clinic for any reason other than active, metastatic cancer

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Helen K. Chew, MD

  University of California, Davis

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: September 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: January 12, 2016
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

US (1)