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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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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 CenterCleveland, Ohio  44106-5065