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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE8107 | Other Identifier | Case Comprehensive Cancer Center | |
| CASE-8107-CC441 | Other Identifier | Cancer Center IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Diagnostic procedures, such as laser spectroscopy, may help find and diagnose breast cancer.
PURPOSE: This phase I trial is studying laser spectroscopy to see how well it works in diagnosing breast cancer in women with breast lesions.
OBJECTIVES:
Primary
OUTLINE: Patients undergo tissue sample collection via needle biopsy or surgical excision of a breast lesion. A radiogram of the sample may be obtained to identify target areas for spectroscopic evaluation. The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy. After completion of the spectroscopic examination, the tissue samples are submitted for diagnostic pathologic evaluation. Hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis. The results of the pathological examination are then compared with the spectroscopic findings and radiological findings (if the biopsy was performed for a suspect lesion on mammography) to determine if any correlation can be established and which spectroscopic technique provides the most useful diagnostic information. Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
Patients' medical charts are reviewed to obtain clinical information (e.g., age, sex, and race; results of pathology reports and reports of ancillary studies, including estrogen receptor, progesterone receptor, and HER-2 receptor testing, for the surgical specimen being studied and for any other related surgical specimens; menstrual status and date of last menstrual period; clinical history of breast mass or abnormal mammogram and related mammography report; clinical history of hormone replacement therapy, birth control pills, or oophorectomy; and clinical history of chemotherapy or other adjuvant therapy for breast cancer).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorescence in situ hybridization | Genetic | Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results. | ||
| immunohistochemistry staining method | Other | Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results. | ||
| medical chart review | Other | Patients' medical charts are reviewed to obtain clinical information | ||
| fluorescence spectroscopy | Procedure | The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy. | ||
| histopathologic examination | Procedure | Hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability of laser spectroscopy performed ex vivo to effectively distinguish between benign and malignant breast tumors | The data will be taken with a portable spectroscopy system that can perform fluorescence, reflectance and Raman spectroscopy simultaneously through a single fiber optic probe. | At the time of biopsy |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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This study will involve up to 200 female patients already undergoing needle biopsy or surgical excision of a breast lesion identified clinically. The patients will be recruited from the General Surgery and Radiology practices of the co-investigators.
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| Name | Affiliation | Role |
|---|---|---|
| Maryann Fitzmaurice, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017404 | In Situ Hybridization, Fluorescence |
| D007150 | Immunohistochemistry |
| D013050 | Spectrometry, Fluorescence |
| ID | Term |
|---|---|
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
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This study will involve up to 200 female patients already undergoing needle biopsy or surgical excision of a breast lesion identified clinically.
| light-scattering spectroscopy | Procedure | The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D006651 | Histocytochemistry |
| D007158 | Immunologic Techniques |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D013057 | Spectrum Analysis |