ID

31890

Description

Topical Itraconazole in the Treatment of Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02120677

Link

https://clinicaltrials.gov/show/NCT02120677

Keywords

Versions (1)
  1. 10/7/18 10/7/18 -
Copyright Holder

Johns Hopkins University

Uploaded on

October 7, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT02120677

English

Eligibility Basal Cell Carcinoma NCT02120677

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must be over the age of 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
male
Description

Male

Data type

boolean

Alias
UMLS CUI [1]
C1706180
women who do not have child-bearing potential (history of hysterectomy, post-menopausal)
Description

Women without child-bearing potential

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332268
have a biopsy confirmed bcc that measures at least 6mm in size at the time of the initial evaluation (visit #1);
Description

Biopsy confirmed bcc

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0005558
UMLS CUI [2]
C0449453
participant must be willing and comply with the requirements of the protocol;
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
participant must have the ability to understand and communicate with the investigator;
Description

Able to understand and communicate

Data type

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2]
C0162340
participant must provide informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject with significant congestive heart failure (chf) or history of chf, chronic renal failure, hepatic failure, neuropathy
Description

History of Congestive heart failure, chronic renal failure, hepatic failure, neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0262926
UMLS CUI [3]
C0022661
UMLS CUI [4]
C0085605
UMLS CUI [5]
C0442874
subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous t-cell lymphoma, erythroderma;
Description

Skin diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0036043
UMLS CUI [2,1]
C0011615
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0079773
UMLS CUI [4]
C0598398
subjects on systemic medications known to affect the hedgehog pathway (see appendix i)
Description

Systemic medication affecting hedgehog pathway

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1155468
subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine
Description

Cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol, lovastatin, simvastatin, dihydroergotamine, ergometrine, ergotamine and methylergometrine

Data type

boolean

Alias
UMLS CUI [1]
C0072916
UMLS CUI [2,1]
C0026056
UMLS CUI [2,2]
C0442027
UMLS CUI [3]
C0028116
UMLS CUI [4]
C0015772
UMLS CUI [5]
C0031935
UMLS CUI [6]
C0034414
UMLS CUI [7]
C0114771
UMLS CUI [8]
C0040879
UMLS CUI [9]
C0025605
UMLS CUI [10]
C0772342
UMLS CUI [11]
C0024027
UMLS CUI [12]
C0074554
UMLS CUI [13]
C0012291
UMLS CUI [14]
C0014710
UMLS CUI [15]
C0025760
subjects with history of hypersensitivity to azoles
Description

Hypersensitivity to azoles

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004504
subjects with gorlin syndrome
Description

Gorlin Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0004779
subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than bcc/squamous cell skin cancers)
Description

Chronic immunosuppression or history of compromised immune function

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0205394
subjects who do not speak english or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
Description

Not able to speak english or hearing disorder, not able to provide informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C1384666
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0332268
UMLS CUI [4,2]
C2364293
UMLS CUI [4,3]
C0035173
subjects with a history of keloids or excessive scarring;
Description

History of keloids or excessive scarring

Data type

boolean

Alias
UMLS CUI [1,1]
C0022548
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0008767
UMLS CUI [2,3]
C0442802
subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum
Description

Allergy to lidocaine, epinephrine, itraconazole or petrolatum

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014563
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0023660
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0064113
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0031262
women of child-bearing age/potential and/or able to conceive
Description

Women of child-bearing age and able to conceive

Data type

boolean

Alias
UMLS CUI [1]
C3831118
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Similar models

Eligibility Basal Cell Carcinoma NCT02120677

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
participants must be over the age of 18 years
boolean
C0001779 (UMLS CUI [1])
Male
Item
male
boolean
C1706180 (UMLS CUI [1])
Women without child-bearing potential
Item
women who do not have child-bearing potential (history of hysterectomy, post-menopausal)
boolean
C3831118 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Biopsy confirmed bcc
Item
have a biopsy confirmed bcc that measures at least 6mm in size at the time of the initial evaluation (visit #1);
boolean
C0007117 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2])
Protocol Compliance
Item
participant must be willing and comply with the requirements of the protocol;
boolean
C0525058 (UMLS CUI [1])
Able to understand and communicate
Item
participant must have the ability to understand and communicate with the investigator;
boolean
C2364293 (UMLS CUI [1])
C0162340 (UMLS CUI [2])
Informed consent
Item
participant must provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
History of Congestive heart failure, chronic renal failure, hepatic failure, neuropathy
Item
subject with significant congestive heart failure (chf) or history of chf, chronic renal failure, hepatic failure, neuropathy
boolean
C0018802 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0022661 (UMLS CUI [3])
C0085605 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
Skin diseases
Item
subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous t-cell lymphoma, erythroderma;
boolean
C0037274 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
C0011615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0079773 (UMLS CUI [3])
C0598398 (UMLS CUI [4])
Systemic medication affecting hedgehog pathway
Item
subjects on systemic medications known to affect the hedgehog pathway (see appendix i)
boolean
C1515119 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1155468 (UMLS CUI [1,3])
Cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol, lovastatin, simvastatin, dihydroergotamine, ergometrine, ergotamine and methylergometrine
Item
subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine
boolean
C0072916 (UMLS CUI [1])
C0026056 (UMLS CUI [2,1])
C0442027 (UMLS CUI [2,2])
C0028116 (UMLS CUI [3])
C0015772 (UMLS CUI [4])
C0031935 (UMLS CUI [5])
C0034414 (UMLS CUI [6])
C0114771 (UMLS CUI [7])
C0040879 (UMLS CUI [8])
C0025605 (UMLS CUI [9])
C0772342 (UMLS CUI [10])
C0024027 (UMLS CUI [11])
C0074554 (UMLS CUI [12])
C0012291 (UMLS CUI [13])
C0014710 (UMLS CUI [14])
C0025760 (UMLS CUI [15])
Hypersensitivity to azoles
Item
subjects with history of hypersensitivity to azoles
boolean
C0020517 (UMLS CUI [1,1])
C0004504 (UMLS CUI [1,2])
Gorlin Syndrome
Item
subjects with gorlin syndrome
boolean
C0004779 (UMLS CUI [1])
Chronic immunosuppression or history of compromised immune function
Item
subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than bcc/squamous cell skin cancers)
boolean
C0021079 (UMLS CUI [1])
C4048329 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Not able to speak english or hearing disorder, not able to provide informed consent
Item
subjects who do not speak english or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
boolean
C0376245 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1384666 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0332268 (UMLS CUI [4,1])
C2364293 (UMLS CUI [4,2])
C0035173 (UMLS CUI [4,3])
History of keloids or excessive scarring
Item
subjects with a history of keloids or excessive scarring;
boolean
C0022548 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0008767 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
Allergy to lidocaine, epinephrine, itraconazole or petrolatum
Item
subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum
boolean
C0020517 (UMLS CUI [1,1])
C0014563 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0023660 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0064113 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0031262 (UMLS CUI [4,2])
Women of child-bearing age and able to conceive
Item
women of child-bearing age/potential and/or able to conceive
boolean
C3831118 (UMLS CUI [1])
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