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Completed

NCT Number: NCT00900133

Study of Calgranulin A/B Levels in Patients With Newly Diagnosed Stage I,II,III 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunoenzyme technique

Other

Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.

laboratory biomarker analysis

Other

Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B.

Primary outcomes

  1. Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer

    Time frame: upon diagnosis

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 12, 2009
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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