Clinical trial NCT00900133: Study of Calgranulin A/B Levels in Patients With Newly Diagnosed Stage I,II,III Breast Cancer
Official title: A Pilot Trial to Correlate Serum Levels of Calgranulin A and B With Estrogen Receptor Status Among Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients With Newly Diagnosed Stage I,II,III Breast Cancer. Primary care clinic

Brief 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.

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 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

Primary outcomes:
measure: Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer
timeFrame: upon diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: John Pink, PhD
role: PRINCIPAL_INVESTIGATOR
References: