ID

35099

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02436408

Trefwoorden

Versies (1)
  1. 16-02-19 16-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Basal Cell NCT02436408

Engels

Eligibility Carcinoma, Basal Cell NCT02436408

1 Formulieren  
Inclusion Criteria
Beschrijving

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.
Beschrijving

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

Datatype

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.
Beschrijving

Assessment Clinical Score

Datatype

boolean

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

Screening Oncologic

Datatype

boolean

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

Basal cell carcinoma Size | Basal cell carcinoma Location

Datatype

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.
Beschrijving

Capacity Hematopoietic | Liver function | Renal function

Datatype

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.
Beschrijving

Gender Male Condoms

Datatype

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.
Beschrijving

Gender | Sperm donation Absent

Datatype

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.
Beschrijving

Blood Donation Absent

Datatype

boolean

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

Informed Consent

Datatype

boolean

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

Blood Biomarker Analysis

Datatype

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.
Beschrijving

Patient Present Clinic Visits

Datatype

boolean

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

Exclusion Criteria

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

Lacking Able to swallow Capsule | Swallow Capsule Unwilling

Datatype

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.
Beschrijving

Protocol Compliance Unable | Protocol Compliance Unwilling

Datatype

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.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Childbearing Potential

Datatype

boolean

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

Illness Uncontrolled

Datatype

boolean

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Carcinoma, Basal Cell NCT02436408

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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