ID

43060

Beschrijving

Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas; ODM derived from: https://clinicaltrials.gov/show/NCT01108094

Link

https://clinicaltrials.gov/show/NCT01108094

Trefwoorden

Versies (1)
  1. 18-09-21 18-09-21 -
Houder van rechten

Stanford University

Geüploaded op

18 september 2021

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Skin Cancers NCT01108094

Engels

Eligibility Skin Cancers NCT01108094

1 Formulieren  
Inclucion Criteria
Beschrijving

Inclucion Criteria

At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be biopsied and surgically removed.
Beschrijving

Basal cell carcinoma diameter | BCC planned to be biopsied and surgically removed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0005558
UMLS CUI [2,4]
C1301732
had at least one liver function test (ast, alt) with normal results in the last year.
Beschrijving

Recent liver function test with a normal result | ALT | AST

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C0459422
UMLS CUI [1,3]
C0332185
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
willing to take drug during the 2-3 weeks between biopsy and surgical removal of bcc.
Beschrijving

Willing to take drug during the time period between biopsy and surgical removal of BCC

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C1948053
UMLS CUI [1,4]
C0005558
UMLS CUI [1,5]
C0007117
UMLS CUI [1,6]
C0600109
consent to research use of their bcc tissue.
Beschrijving

Consent to research use of their BCC tissue

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0040300
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0008972
UMLS CUI [1,5]
C1511481
Exclusion Criteria
Beschrijving

Exclusion Criteria

History or current hepatitis or other liver disease
Beschrijving

History of hepatitis | Current hepatitis | Other liver disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019158
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0019158
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205394
currently taking systemic medications that would affect bcc tumors (oral retinoids) or metabolism of itraconazole (anti-convulsants, corticosteroids)
Beschrijving

Oral retinoids | Anti-convulsants | Systemic adrenal cortex hormones

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035339
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0003286
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205373
history or current evidence of malabsorption or liver disease that would impair the absorption of itraconazole as measured by liver function tests within the past one year prior to enrollment.
Beschrijving

Malabsorption | Liver disease that would impair the absorption of itraconazole

Datatype

boolean

Alias
UMLS CUI [1]
C3714745
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0064113
UMLS CUI [2,4]
C0237442
history or current evidence of hyperthyroidism that would increase metabolism of itraconazole.
Beschrijving

Hyperthyroidism that would increase metabolism of itraconazole

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0064113
UMLS CUI [1,3]
C0025519
UMLS CUI [1,4]
C0442805
unable to attend to 2nd study visit at stanford for mohs surgical excision
Beschrijving

Unable to attend to 2nd study visit at stanford for mohs surgical excision

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C0020028
UMLS CUI [1,3]
C1299582
UMLS CUI [1,4]
C0079850
current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
Beschrijving

Current immunosuppression | Malignant neoplasms | Autoimmune diseases | Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0521116
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0004364
UMLS CUI [4]
C0021079
pregnant or lactating female
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any female that is trying to get pregnant
Beschrijving

Planned pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032992
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Similar models

Eligibility Skin Cancers NCT01108094

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclucion Criteria
Basal cell carcinoma diameter | BCC planned to be biopsied and surgically removed
Item
At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be biopsied and surgically removed.
boolean
C0007117 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C1301732 (UMLS CUI [2,4])
Recent liver function test with a normal result | ALT | AST
Item
had at least one liver function test (ast, alt) with normal results in the last year.
boolean
C0023901 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Willing to take drug during the time period between biopsy and surgical removal of BCC
Item
willing to take drug during the 2-3 weeks between biopsy and surgical removal of bcc.
boolean
C0543467 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
C0007117 (UMLS CUI [1,5])
C0600109 (UMLS CUI [1,6])
Consent to research use of their BCC tissue
Item
consent to research use of their bcc tissue.
boolean
C0007117 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
C1511481 (UMLS CUI [1,5])
Item Group
Exclusion Criteria
History of hepatitis | Current hepatitis | Other liver disease
Item
History or current hepatitis or other liver disease
boolean
C0262926 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0019158 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Oral retinoids | Anti-convulsants | Systemic adrenal cortex hormones
Item
currently taking systemic medications that would affect bcc tumors (oral retinoids) or metabolism of itraconazole (anti-convulsants, corticosteroids)
boolean
C0035339 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0003286 (UMLS CUI [2])
C0001617 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Malabsorption | Liver disease that would impair the absorption of itraconazole
Item
history or current evidence of malabsorption or liver disease that would impair the absorption of itraconazole as measured by liver function tests within the past one year prior to enrollment.
boolean
C3714745 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0064113 (UMLS CUI [2,3])
C0237442 (UMLS CUI [2,4])
Hyperthyroidism that would increase metabolism of itraconazole
Item
history or current evidence of hyperthyroidism that would increase metabolism of itraconazole.
boolean
C0020550 (UMLS CUI [1,1])
C0064113 (UMLS CUI [1,2])
C0025519 (UMLS CUI [1,3])
C0442805 (UMLS CUI [1,4])
Unable to attend to 2nd study visit at stanford for mohs surgical excision
Item
unable to attend to 2nd study visit at stanford for mohs surgical excision
boolean
C0008952 (UMLS CUI [1,1])
C0020028 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0079850 (UMLS CUI [1,4])
Current immunosuppression | Malignant neoplasms | Autoimmune diseases | Therapeutic immunosuppression
Item
current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
boolean
C4048329 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Planned pregnancy
Item
any female that is trying to get pregnant
boolean
C0032992 (UMLS CUI [1])
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