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

This study has been completed.

First Received: May 9, 2009 Last Updated: May 16, 2009 History of Changes

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00900133

Purpose

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.

Condition	Intervention
Breast Cancer	Other: immunoenzyme technique Other: laboratory biomarker analysis

Study Type:	Observational
Official Title:	A Pilot Trial to Correlate Serum Levels of Calgranulin A and B With Estrogen Receptor Status Among Patients With Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer [ Designated as safety issue: No ]

Study Start Date:

January 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900133

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

John Pink, PhD

Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000448632, CASE-7104
Study First Received:	May 9, 2009
Last Updated:	May 16, 2009
ClinicalTrials.gov Identifier:	NCT00900133 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010