ID

39881

Beskrivning

Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC); ODM derived from: https://clinicaltrials.gov/show/NCT01252329

Länk

https://clinicaltrials.gov/show/NCT01252329

Nyckelord

Versioner (1)
  1. 2020-02-27 2020-02-27 -
Rättsinnehavare

See clinicaltrials.gov

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27 februari 2020

DOI

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Creative Commons BY 4.0
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Eligibility High Risk Cutaneous Squamous Cell Carcinoma NCT01252329

Engelsk

Eligibility High Risk Cutaneous Squamous Cell Carcinoma NCT01252329

1 Formulär  
Criteria
Beskrivning

Criteria

major criterion: > 6 mm depth of invasion
Beskrivning

Criterion Main | Depth Invasion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1542147
UMLS CUI [2,1]
C0205125
UMLS CUI [2,2]
C1269955
minor criteria (one or more):
Beskrivning

Criteria Minor Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205165
UMLS CUI [1,3]
C1265611
greater than 2cm diameter
Beskrivning

Diameter

Datatyp

boolean

Alias
UMLS CUI [1]
C1301886
recurrent (prior mohs, wide local excision, electrodesiccation and curettage, topical imiquimod or 5 fluorouracil, cryotherapy or photodynamic therapy)
Beskrivning

Recurrent disease | Mohs Surgery | Wide Local Excision | Electrodesiccation with curettage | Imiquimod Topical | 5-Fluorouracil | Cold Therapy | Photochemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0079850
UMLS CUI [3]
C2986517
UMLS CUI [4]
C0185058
UMLS CUI [5]
C3215046
UMLS CUI [6]
C0016360
UMLS CUI [7]
C0010412
UMLS CUI [8]
C0031740
high risk location: any portion of cutaneous lip, ear, temple, scalp
Beskrivning

High risk Location | Lip Portion Cutaneous | Ear Portion Cutaneous | Temple Portion Cutaneous | Scalp Portion Cutaneous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0023759
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C0221912
UMLS CUI [3,1]
C0013443
UMLS CUI [3,2]
C0449719
UMLS CUI [3,3]
C0221912
UMLS CUI [4,1]
C0935456
UMLS CUI [4,2]
C0449719
UMLS CUI [4,3]
C0221912
UMLS CUI [5,1]
C0036270
UMLS CUI [5,2]
C0449719
UMLS CUI [5,3]
C0221912
immunosuppressed host (organ transplant recipient or chronic lymphocytic leukemia)
Beskrivning

Immunocompromised Host | Organ transplant Recipient | Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2,1]
C0524930
UMLS CUI [2,2]
C1709854
UMLS CUI [3]
C0023434
perineural invasion (yes/no; nerve involved must be greater than 0.1mm)
Beskrivning

Perineural invasion | Size Nerve Involved

Datatyp

boolean

Alias
UMLS CUI [1]
C1300724
UMLS CUI [2,1]
C0456389
UMLS CUI [2,2]
C0027740
UMLS CUI [2,3]
C1314939
direct involvement of subcutaneous tissue (clark's v), muscle, cartilage,or bone
Beskrivning

Involvement Subcutaneous Tissue | Clark's melanoma level | Involvement Muscle | Involvement Cartilage | Involvement Bone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0278403
UMLS CUI [2]
C0449387
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0026845
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0007301
UMLS CUI [5,1]
C1314939
UMLS CUI [5,2]
C0262950
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
satellite metastases
Beskrivning

Satellite Metastases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332221
UMLS CUI [1,2]
C0027627
clinically abnormal lymph node exam
Beskrivning

Abnormality of the lymph nodes

Datatyp

boolean

Alias
UMLS CUI [1]
C0149727
location other than head or neck
Beskrivning

Location Except Head | Location Except Neck

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0018670
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0027530
exclusively mucosal squamous cell carcinoma
Beskrivning

Squamous cell carcinoma Mucosal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C0026724
previous head and neck radiation
Beskrivning

Radiation therapy to the head and neck Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4540910
UMLS CUI [1,2]
C0205156
in situ disease, keratoacanthoma subtypes, metatypical or collision tumors
Beskrivning

Disease In situ | Keratoacanthoma Subtype | Metatypical Carcinoma | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0444498
UMLS CUI [2,1]
C0022572
UMLS CUI [2,2]
C0449560
UMLS CUI [3]
C0007118
UMLS CUI [4]
C3846158
inability of subject to give written informed consent
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility High Risk Cutaneous Squamous Cell Carcinoma NCT01252329

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Criterion Main | Depth Invasion
Item
major criterion: > 6 mm depth of invasion
boolean
C0243161 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0205125 (UMLS CUI [2,1])
C1269955 (UMLS CUI [2,2])
Criteria Minor Quantity
Item
minor criteria (one or more):
boolean
C0243161 (UMLS CUI [1,1])
C0205165 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Diameter
Item
greater than 2cm diameter
boolean
C1301886 (UMLS CUI [1])
Recurrent disease | Mohs Surgery | Wide Local Excision | Electrodesiccation with curettage | Imiquimod Topical | 5-Fluorouracil | Cold Therapy | Photochemotherapy
Item
recurrent (prior mohs, wide local excision, electrodesiccation and curettage, topical imiquimod or 5 fluorouracil, cryotherapy or photodynamic therapy)
boolean
C0277556 (UMLS CUI [1])
C0079850 (UMLS CUI [2])
C2986517 (UMLS CUI [3])
C0185058 (UMLS CUI [4])
C3215046 (UMLS CUI [5])
C0016360 (UMLS CUI [6])
C0010412 (UMLS CUI [7])
C0031740 (UMLS CUI [8])
High risk Location | Lip Portion Cutaneous | Ear Portion Cutaneous | Temple Portion Cutaneous | Scalp Portion Cutaneous
Item
high risk location: any portion of cutaneous lip, ear, temple, scalp
boolean
C4319571 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0023759 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0221912 (UMLS CUI [2,3])
C0013443 (UMLS CUI [3,1])
C0449719 (UMLS CUI [3,2])
C0221912 (UMLS CUI [3,3])
C0935456 (UMLS CUI [4,1])
C0449719 (UMLS CUI [4,2])
C0221912 (UMLS CUI [4,3])
C0036270 (UMLS CUI [5,1])
C0449719 (UMLS CUI [5,2])
C0221912 (UMLS CUI [5,3])
Immunocompromised Host | Organ transplant Recipient | Chronic Lymphocytic Leukemia
Item
immunosuppressed host (organ transplant recipient or chronic lymphocytic leukemia)
boolean
C0085393 (UMLS CUI [1])
C0524930 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
C0023434 (UMLS CUI [3])
Perineural invasion | Size Nerve Involved
Item
perineural invasion (yes/no; nerve involved must be greater than 0.1mm)
boolean
C1300724 (UMLS CUI [1])
C0456389 (UMLS CUI [2,1])
C0027740 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
Involvement Subcutaneous Tissue | Clark's melanoma level | Involvement Muscle | Involvement Cartilage | Involvement Bone
Item
direct involvement of subcutaneous tissue (clark's v), muscle, cartilage,or bone
boolean
C1314939 (UMLS CUI [1,1])
C0278403 (UMLS CUI [1,2])
C0449387 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0026845 (UMLS CUI [3,2])
C1314939 (UMLS CUI [4,1])
C0007301 (UMLS CUI [4,2])
C1314939 (UMLS CUI [5,1])
C0262950 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Satellite Metastases
Item
satellite metastases
boolean
C0332221 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Abnormality of the lymph nodes
Item
clinically abnormal lymph node exam
boolean
C0149727 (UMLS CUI [1])
Location Except Head | Location Except Neck
Item
location other than head or neck
boolean
C1515974 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0018670 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0027530 (UMLS CUI [2,3])
Squamous cell carcinoma Mucosal
Item
exclusively mucosal squamous cell carcinoma
boolean
C0007137 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
Radiation therapy to the head and neck Previous
Item
previous head and neck radiation
boolean
C4540910 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Disease In situ | Keratoacanthoma Subtype | Metatypical Carcinoma | Other Coding
Item
in situ disease, keratoacanthoma subtypes, metatypical or collision tumors
boolean
C0012634 (UMLS CUI [1,1])
C0444498 (UMLS CUI [1,2])
C0022572 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C0007118 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Informed Consent Unable
Item
inability of subject to give written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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