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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00900133
Enrollment
60
Registered
2009-05-12
Start date
2005-01-31
Completion date
2006-12-31
Last updated
2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

OTHERimmunoenzyme technique

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

OTHERlaboratory biomarker analysis

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancerupon diagnosis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026