Age | Skin Neoplasms Primary | Secondary malignant neoplasm of skin | Prior radiation therapy
Item
patients > 18 years of age, with primary or metastatic cutaneous tumors that have been previously irradiated.
boolean
C0001779 (UMLS CUI [1])
C0037286 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0153687 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
Target Lesion Identification | Skin of periumbilical region Normal
Item
patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver clipt (10 x 10 cm for target lesion, and 1 x 1 cm for control site).
boolean
C2986546 (UMLS CUI [1])
C0448830 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Target Lesion Identification | Location of lesion Hand Excluded | Location of lesion Foot Excluded | Location of lesion Genitalia Excluded | Location of lesion Face Excluded
Item
patients must have a target lesion in a location other than the hands, feet, genitals, or face. lesions in those locations will be excluded.
boolean
C2986546 (UMLS CUI [1])
C2184261 (UMLS CUI [2,1])
C0018563 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C2184261 (UMLS CUI [3,1])
C0016504 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
C2184261 (UMLS CUI [4,1])
C0017420 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
C2184261 (UMLS CUI [5,1])
C0015450 (UMLS CUI [5,2])
C2828389 (UMLS CUI [5,3])
Informed Consent
Item
patients must sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Cancer treatment Systemic
Item
patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Therapeutic radiology procedure Target Site
Item
patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
boolean
C1522449 (UMLS CUI [1,1])
C2348654 (UMLS CUI [1,2])
Medical condition Associated with Photosensitivity | Porphyria Cutaneous | Collagen-vascular disease | Hypersensitivity Porphyrins
Item
patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0349506 (UMLS CUI [1,3])
C0032708 (UMLS CUI [2,1])
C0221912 (UMLS CUI [2,2])
C0262428 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0032712 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
pregnant and nursing patients will be excluded. women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
Pharmaceutical Preparations Causing Photosensitivity | Tetracyclines | Sulfonamides | Phenothiazines | Sulfonylurea | Hypoglycemic Agents | Thiazide Diuretics | Griseofulvin | Fluoroquinolones
Item
patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones) will be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0349506 (UMLS CUI [1,3])
C0039651 (UMLS CUI [2])
C0038760 (UMLS CUI [3])
C0031436 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0020616 (UMLS CUI [6])
C0012802 (UMLS CUI [7])
C0018242 (UMLS CUI [8])
C0949665 (UMLS CUI [9])
Laboratory Results
Item
laboratory values (note: these are provided by the potential patient):
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count > 1000.
boolean
C0948762 (UMLS CUI [1])
Liver Dysfunction Severe | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
patients with severe hepatic dysfunction (total bilirubin, ast, or alt > five times upper limit of normal) will be excluded.
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Blood coagulation status | Platelet Count measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
adequate coagulation status as indicated by platelet count > 50,000, pt and ptt < 1.5 time the upper limit of normal.
boolean
C1321069 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
C0030605 (UMLS CUI [4])
Urine pregnancy test negative | Serum pregnancy test negative
Item
negative urine or serum pregnancy test
boolean
C0430057 (UMLS CUI [1])
C0430061 (UMLS CUI [2])
Cost Patient Absent | Compensation Absent
Item
note: no cost to patient, and no compensation provided.
boolean
C0010186 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0220808 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])