Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy

NCT00530569 | Unknown DMC

• 1 other identifier: 17924
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

About 30% of breast cancers have higher than normal levels of a cellular marker called HER2. The amount of HER2 is often measured in breast tissue. A higher level of this marker usually indicates a more aggressive type of breast cancer. Cytokeratin is a second cellular marker found in breast cancer cells. Detection of Circulating cytokeratin in the blood could indicate the presence of cancer. The Pathology Department of the Tom Baker Cancer Center is doing this study to see if measuring the levels of circulating HER2 and cytokeratin, through blood testing has clinical significance for patients with breast cancer.

Conditions

Breast Cancer

Keywords

Breast Cancer; Herceptin Therapy

Interventions

Blood Test PROCEDURE

CBC and HER2 level at baseline, prior to each chemo and/or herceptin cycle, one month after chemo and/or herceptin completion, quarterly up to 12 months or a maximum of 20 blood draws.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Albertan women with breast cancer who will undergo Herceptin therapy as part of their treatment at some point during a one-year period.

You may qualify if:

• Albertan women with breast cancer who will undergo Herceptin therapy as part of their treatment at some point during a one-year period.

You may not qualify if:

• Greater than 80 years of age
• Previous cancer diagnosis - (other than skin cancer)

Sponsors & Collaborators

• Alberta Health services: lead

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bill Kangerloo, M.D.

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: August 1, 2007
• Last Updated: January 28, 2013

Record last verified: 2012-01

Locations

CA (1)