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Study of Calgranulin A/B Levels in Patients With Newly Diagnosed Stage I,II,III Breast Cancer
This study has been completed.

First Received on May 9, 2009.   Last Updated on June 9, 2010   History of Changes
Sponsor: Case Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: Case Comprehensive Cancer Center
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
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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 Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer [ Time Frame: upon diagnosis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers.


Enrollment: 60
Study Start Date: January 2005
Study Completion Date: December 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: immunoenzyme technique
    Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.
    Other: laboratory biomarker analysis
    Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B.
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
Sampling Method:   Probability Sample
Study Population

Patients With Newly Diagnosed Stage I,II,III Breast Cancer. Primary care clinic

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

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: John Pink, PhD Ireland Cancer Center at University Hospitals Case Medical Center, 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

Responsible Party: John Pink, PhD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00900133     History of Changes
Other Study ID Numbers: CASE7104, P30CA043703, CASE-7104
Study First Received: May 9, 2009
Last Updated: June 9, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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