Eligibility Breast Cancer NCT01262716

1 Formulários

StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT01262716

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age | Skin Neoplasms | Secondary malignant neoplasm of skin | Prior radiation therapy | Prior radiation therapy Absent

Item

patients > 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.

boolean

C0001779 (UMLS CUI [1])
C0037286 (UMLS CUI [2])
C0153687 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
C0279134 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])

ECOG performance status

Item

ecog performance status < 3.

boolean

C1520224 (UMLS CUI [1])

Absence Cancer treatment Systemic

Item

patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.

boolean

C0332197 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])

Absence 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

C0332197 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C2348654 (UMLS CUI [1,3])

Skin Target Site Grade | Skin Control Site Grade

Item

skin of target site and control site must be grade 0 or 1 by common terminology

boolean

C1123023 (UMLS CUI [1,1])
C2348654 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1123023 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C0441800 (UMLS CUI [2,4])

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, or 3 x 3).

boolean

C2986546 (UMLS CUI [1])
C0448830 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])

Target Lesion Location Extremity | Target Lesion Percentage Diameter Extremity

Item

if located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located.

boolean

C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0015385 (UMLS CUI [2,4])

Absolute neutrophil count

Item

absolute neutrophil count > 1000.

boolean

C0948762 (UMLS CUI [1])

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])

Informed Consent

Item

patients must sign informed consent.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Gender

Item

male patients not considered for this study.

boolean

C0079399 (UMLS CUI [1])

Target Lesion Location Hands | Target Lesion Location Feet | Target Lesion Location Genitals | Target Lesion Location Face

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 [1,1])
C1515974 (UMLS CUI [1,2])
C0018563 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0016504 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C0017420 (UMLS CUI [3,3])
C2986546 (UMLS CUI [4,1])
C1515974 (UMLS CUI [4,2])
C0015450 (UMLS CUI [4,3])

Medical condition Associated with Photosensitivity | Porphyria variegata, 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])
C0543653 (UMLS CUI [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])

Item

patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, st. john's wort and amiodarone) will be excluded.

boolean

C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0349506 (UMLS CUI [1,3])
C0039644 (UMLS CUI [2])
C0038760 (UMLS CUI [3])
C0031434 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0020616 (UMLS CUI [6])
C0012802 (UMLS CUI [7])
C0018242 (UMLS CUI [8])
C0949665 (UMLS CUI [9])
C0813171 (UMLS CUI [10])
C0002598 (UMLS CUI [11])

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])

Voltar ao início da página

ID

Descrição

Link

Palavras-chave

Versões (1)

Titular dos direitos

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Eligibility Breast Cancer NCT01262716