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| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-GI-0561 | |||
| VU-VICC-IRB-051020 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin.
PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.
OBJECTIVES:
OUTLINE: This is a pilot study.
Patients undergo skin punch biopsies and blood sample collection at baseline, within 1 week of developing skin rash, and 6 weeks after beginning treatment. Samples are analyzed by immunohistochemistry and western blot for phosphorylated MAP kinase, AKT, and EGF levels and TGFα levels. Patients also complete diagrams to indicate locations of the rash once weekly during the first 6 weeks of treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzyme inhibitor therapy | Drug | enzyme inhibitor therapy | ||
| protein expression analysis | Genetic | protein expression analysis | ||
| immunohistochemistry staining method | Other | immunohistochemistry staining method | ||
| laboratory biomarker analysis | Other | laboratory biomarker analysis | ||
| biopsy | Procedure | biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors | baseline and at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin | at 6 weeks | |
| Comparison of changes in the EGFR pathway with grade of rash | at 6 weeks |
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DISEASE CHARACTERISTICS:
Diagnosis of a malignancy for which therapy on or off a clinical trial with an inhibitor of the EGFR pathway is under consideration
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients must be ≥ 18 years of age, have the diagnosis of a malignancy for which they are considering therapy with an inhibitor of the EGFR pathway, have no severe underlying skin disorder, must not have a bleeding diathesis that would preclude safe biopsy and patients on coumadin must not have an INR > 3.0 at time of biopsy.
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| Name | Affiliation | Role |
|---|---|---|
| Laura Goff, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot | at 6 weeks |
| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
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