Study of Calgranulin A/B Levels in Patients With Newly Diagnosed Stage I,II,III Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Pilot Trial to Correlate Serum Levels of Calgranulin A and B With Estrogen Receptor Status Among Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900133
• Other study ID #: CASE7104
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: October 1, 2015
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: October 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Measuring levels of calgranulin A and calgranulin B in the blood of patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to breast cancer.

PURPOSE: This laboratory study is measuring calgranulin A and calgranulin B levels in the blood of patients with newly diagnosed stage I, stage II, or stage III breast cancer.

Description:

OBJECTIVES:

• Determine circulating levels of calgranulin A and calgranulin B in patients with estrogen receptor negative or estrogen receptor positive, newly diagnosed, primary stage I-III adenocarcinoma of the breast.

OUTLINE: This is a pilot study.

Patients undergo a blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B. Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed primary adenocarcinoma of the breast

• Stage I-III disease

• No evidence of metastatic disease

• Newly diagnosed disease

• Hormone receptor status:

• Estrogen receptor-positive- or -negative tumor

PATIENT CHARACTERISTICS:

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant

• No Crohn's disease

• No arthritis

• No psoriasis

• No lupus erythematosus

• No multiple sclerosis

• No other severe active inflammation

• Not C-reactive protein positive

• No HIV positivity

• No other serious medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

Radiotherapy

• No prior radiotherapy for breast cancer

Surgery

• No prior organ transplantation

Other

• No prior systemic therapy for breast cancer

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• immunoenzyme technique
Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.
• laboratory biomarker analysis
Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer		upon diagnosis	No