ID

39881

Description

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

Link

https://clinicaltrials.gov/show/NCT01252329

Keywords

Versions (1)
  1. 2/27/20 2/27/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 27, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility High Risk Cutaneous Squamous Cell Carcinoma NCT01252329

English

Eligibility High Risk Cutaneous Squamous Cell Carcinoma NCT01252329

1 forms  
Criteria
Description

Criteria

major criterion: > 6 mm depth of invasion
Description

Criterion Main | Depth Invasion

Data type

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):
Description

Criteria Minor Quantity

Data type

boolean

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

Diameter

Data type

boolean

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

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

Data type

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
Description

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

Data type

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)
Description

Immunocompromised Host | Organ transplant Recipient | Chronic Lymphocytic Leukemia

Data type

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)
Description

Perineural invasion | Size Nerve Involved

Data type

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
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
satellite metastases
Description

Satellite Metastases

Data type

boolean

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

Abnormality of the lymph nodes

Data type

boolean

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

Location Except Head | Location Except Neck

Data type

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
Description

Squamous cell carcinoma Mucosal

Data type

boolean

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

Radiation therapy to the head and neck Previous

Data type

boolean

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

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

Data type

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
Description

Informed Consent Unable

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Back to the top of the page

Similar models

Eligibility High Risk Cutaneous Squamous Cell Carcinoma NCT01252329

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial