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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.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00900133
First received: May 9, 2009
Last updated: June 9, 2010
Last verified: June 2010

May 9, 2009
June 9, 2010
January 2005
April 2006   (final data collection date for primary outcome measure)
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 ]
Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00900133 on ClinicalTrials.gov Archive Site
Not Provided
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Study of Calgranulin A/B Levels in Patients With Newly Diagnosed Stage I,II,III Breast Cancer
A Pilot Trial to Correlate Serum Levels of Calgranulin A and B With Estrogen Receptor Status Among Patients With Breast Cancer

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

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

Breast Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00900133
CASE7104, P30CA043703, CASE-7104
Yes
John Pink, PhD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: John Pink, PhD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP