A Pilot Trial to Correlate Serum Levels of Calgranulin A and B With Estrogen Receptor Status Among Patients With Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
A Pilot Trial to Correlate Serum Levels of Calgranulin A and B With Estrogen Receptor Status Among Patients With Breast Cancer
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Outcome Measure:
Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer
Outcome Time Frame:
upon diagnosis
Safety Issue:
No
Principal Investigator
John Pink, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE7104
NCT ID:
NCT00900133
Start Date:
January 2005
Completion Date:
December 2006
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
