ID

35099

Description

VISmodegib for ORbital and Periocular Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02436408

Link

https://clinicaltrials.gov/show/NCT02436408

Keywords

Versions (1)
  1. 2/16/19 2/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 16, 2019

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 Carcinoma, Basal Cell NCT02436408

English

Eligibility Carcinoma, Basal Cell NCT02436408

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients over 18 years of age with locally advanced or recurrent orbital or periorbital basal cell carcinoma (bcca), or a medial canthal bcca that threatens the lacrimal drainage system.
Description

Adult | Age | Basal cell carcinoma Orbital Advanced Locally | Basal cell carcinoma Periorbital Advanced Locally | Recurrent basal cell carcinoma Orbital | Recurrent basal cell carcinoma Periorbital | Basal cell carcinoma Medial canthus At risk Lacrimal drainage

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C0699036
UMLS CUI [3,3]
C0205179
UMLS CUI [3,4]
C1517927
UMLS CUI [4,1]
C0007117
UMLS CUI [4,2]
C0230064
UMLS CUI [4,3]
C0205179
UMLS CUI [4,4]
C1517927
UMLS CUI [5,1]
C1304307
UMLS CUI [5,2]
C0699036
UMLS CUI [6,1]
C1304307
UMLS CUI [6,2]
C0230064
UMLS CUI [7,1]
C0007117
UMLS CUI [7,2]
C0229247
UMLS CUI [7,3]
C1444641
UMLS CUI [7,4]
C0423157
clinical assessment score obtained at baseline.
Description

Assessment Clinical Score

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0449820
medical oncology screening performed at baseline.
Description

Screening Oncologic

Data type

boolean

Alias
UMLS CUI [1,1]
C1710032
UMLS CUI [1,2]
C0205478
adequate bcca size and location.
Description

Basal cell carcinoma Size | Basal cell carcinoma Location

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1515974
adequate hematopoietic capacity, hepatic and renal function.
Description

Capacity Hematopoietic | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C1998319
UMLS CUI [1,2]
C0229601
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
male patients must agree to use condoms during treatment and for 2 months after last dose.
Description

Gender Male Condoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0009653
male patients must agree to not donate sperm during treatment and for 2 months after last dose.
Description

Gender | Sperm donation Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0871414
UMLS CUI [2,2]
C0332197
participant must agree not to donate blood during the study and for 7 months after last dose.
Description

Blood Donation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332197
informed consent signed.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient must consent to blood biomarker analysis.
Description

Blood Biomarker Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0005767
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C0002778
patient must be able to be present for monthly visits for the duration of the study.
Description

Patient Present Clinic Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C0008952
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability or unwillingness to swallow capsules.
Description

Lacking Able to swallow Capsule | Swallow Capsule Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0006935
UMLS CUI [2,1]
C4521686
UMLS CUI [2,2]
C0006935
UMLS CUI [2,3]
C0558080
inability or unwillingness to comply with study procedures.
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
pregnant, lactating, or breast feeding women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential.
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
uncontrolled medical illness.
Description

Illness Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
age under 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Back to the top of the page

Similar models

Eligibility Carcinoma, Basal Cell NCT02436408

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Basal cell carcinoma Orbital Advanced Locally | Basal cell carcinoma Periorbital Advanced Locally | Recurrent basal cell carcinoma Orbital | Recurrent basal cell carcinoma Periorbital | Basal cell carcinoma Medial canthus At risk Lacrimal drainage
Item
adult patients over 18 years of age with locally advanced or recurrent orbital or periorbital basal cell carcinoma (bcca), or a medial canthal bcca that threatens the lacrimal drainage system.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C0699036 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C1517927 (UMLS CUI [3,4])
C0007117 (UMLS CUI [4,1])
C0230064 (UMLS CUI [4,2])
C0205179 (UMLS CUI [4,3])
C1517927 (UMLS CUI [4,4])
C1304307 (UMLS CUI [5,1])
C0699036 (UMLS CUI [5,2])
C1304307 (UMLS CUI [6,1])
C0230064 (UMLS CUI [6,2])
C0007117 (UMLS CUI [7,1])
C0229247 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0423157 (UMLS CUI [7,4])
Assessment Clinical Score
Item
clinical assessment score obtained at baseline.
boolean
C1516048 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Screening Oncologic
Item
medical oncology screening performed at baseline.
boolean
C1710032 (UMLS CUI [1,1])
C0205478 (UMLS CUI [1,2])
Basal cell carcinoma Size | Basal cell carcinoma Location
Item
adequate bcca size and location.
boolean
C0007117 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
Capacity Hematopoietic | Liver function | Renal function
Item
adequate hematopoietic capacity, hepatic and renal function.
boolean
C1998319 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Gender Male Condoms
Item
male patients must agree to use condoms during treatment and for 2 months after last dose.
boolean
C0079399 (UMLS CUI [1,1])
C0009653 (UMLS CUI [1,2])
Gender | Sperm donation Absent
Item
male patients must agree to not donate sperm during treatment and for 2 months after last dose.
boolean
C0079399 (UMLS CUI [1])
C0871414 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Blood Donation Absent
Item
participant must agree not to donate blood during the study and for 7 months after last dose.
boolean
C0005794 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
informed consent signed.
boolean
C0021430 (UMLS CUI [1])
Blood Biomarker Analysis
Item
patient must consent to blood biomarker analysis.
boolean
C0005767 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
Patient Present Clinic Visits
Item
patient must be able to be present for monthly visits for the duration of the study.
boolean
C0030705 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Lacking Able to swallow Capsule | Swallow Capsule Unwilling
Item
inability or unwillingness to swallow capsules.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C4521686 (UMLS CUI [2,1])
C0006935 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
inability or unwillingness to comply with study procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant, lactating, or breast feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential
Item
women of childbearing potential.
boolean
C3831118 (UMLS CUI [1])
Illness Uncontrolled
Item
uncontrolled medical illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Age
Item
age under 18 years.
boolean
C0001779 (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