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

NCT00900133 | Completed DMC

• 3 other identifiers: CASE7104P30CA043703CASE-7104
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  upon diagnosis

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• John Pink, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

US (1)