ID

36688

Beschreibung

Vismodegib in Treating Patients With Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01631331 Brief Summary: The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell carcinoma (BCCs) prior to surgical removal.

Link

https://clinicaltrials.gov/show/NCT01631331

Stichworte

Versionen (1)
  1. 01.06.19 01.06.19 -
Rechteinhaber

Stanford University

Hochgeladen am

1. Juni 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Vismodegib for Basal Cell Carcinoma NCT01631331

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have at least one BCC, > 5 mm, eligible for Mohs surgical removal? (participants with BCCs that have been treated before (recurrent bccs, bccs that failed other chemotherapy) are eligible for this trial, if they meet size criteria)
Beschreibung

Study patients must have at least one bcc, > 5 mm, eligible for mohs surgical removal; patients with bccs that have been treated before (recurrent bccs, bccs that failed other chemotherapy) are eligible for this trial, if they meet size criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0079850
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C2945760
UMLS CUI [2,4]
C1548635
UMLS CUI [2,5]
C0243161
UMLS CUI [2,6]
C0456389
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1514463
UMLS CUI [3,3]
C3665472
UMLS CUI [3,4]
C0231175
UMLS CUI [3,5]
C1548635
UMLS CUI [3,6]
C0243161
UMLS CUI [3,7]
C0456389
Will no eastern cooperative oncology group (ecog) or karnofsky performance status be employed?
Beschreibung

Both ECOG and Karnofsky are performance statuses

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0445107
UMLS CUI [1,2]
C3541269
UMLS CUI [2,1]
C0445107
UMLS CUI [2,2]
C0206065
Does the participant have normal hepatic function: aspartate aminotransferase (ast) and alanine aminotransferase (alt) =< 2 x the upper limit of normal (uln)?
Beschreibung

Hepatic function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0201899
UMLS CUI [2,1]
C0201836
UMLS CUI [2,2]
C1519815
Does the participant have normal renal function : normal serum creatinine defined as <= 2.5 mg/dl?
Beschreibung

Renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0600061
UMLS CUI [1,3]
C0205307
Does the participant have a clinically acceptable complete blood count (cbc)?
Beschreibung

Complete Blood Count

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009555
UMLS CUI [1,2]
C1879533
ability to understand and the willingness to sign a written informed consent document
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1273101
UMLS CUI [1,2]
C0009797
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C0742766
UMLS CUI [2,3]
C0021430
Is the participant willing to forego surgical treatment of bccs by up to 6 months, except when the principal investigator (pi) believes that delay in treatment potentially might compromise the health of the subject?
Beschreibung

Willingness for Surgical Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0007117
UMLS CUI [1,4]
C0332300
UMLS CUI [1,5]
C1521895
UMLS CUI [1,6]
C0004951
UMLS CUI [1,7]
C0522486
UMLS CUI [1,8]
C2945640
UMLS CUI [1,9]
C0018684
Does the participant have documented negative serum pregnancy test for women of childbearing potential, with agreement to the use of two acceptable methods of contraception during the study and for 7 months after discontinuation of vismodegib?
Beschreibung

Negative pregancy test and contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301725
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C4324275
UMLS CUI [1,4]
C0004764
UMLS CUI [1,5]
C0439064
UMLS CUI [1,6]
C0347984
UMLS CUI [1,7]
C0008976
UMLS CUI [1,8]
C1948053
UMLS CUI [1,9]
C0687676
UMLS CUI [1,10]
C4288399
for men with female partners of childbearing potential, agreement to use a latex, non-latex, or any other male condom and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug
Beschreibung

Male contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009653
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0043210
UMLS CUI [1,4]
C1524062
UMLS CUI [1,5]
C0700589
UMLS CUI [1,6]
C0347984
UMLS CUI [1,7]
C0008976
UMLS CUI [1,8]
C1948053
UMLS CUI [1,9]
C0687676
UMLS CUI [1,10]
C4288399
Is the participant willing to not donate blood or semen for three months following discontinuation of study medications?
Beschreibung

No Blood or Semen donations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C3840725
UMLS CUI [1,3]
C0871414
UMLS CUI [1,4]
C1948053
UMLS CUI [1,5]
C0687676
UMLS CUI [1,6]
C4288399
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C3840725
UMLS CUI [2,3]
C0005794
UMLS CUI [2,4]
C1948053
UMLS CUI [2,5]
C0687676
UMLS CUI [2,6]
C4288399
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have a history of invasive cancer within the past five years excluding non-melanoma skin cancer, stage i cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (cll) stage 0?
Beschreibung

History of invasive cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0677898
UMLS CUI [1,3]
C2828389
UMLS CUI [1,4]
C0007114
UMLS CUI [1,5]
C0332288
UMLS CUI [1,6]
C0025202
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0677898
UMLS CUI [2,3]
C2828389
UMLS CUI [2,4]
C0278575
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0677898
UMLS CUI [3,3]
C2828389
UMLS CUI [3,4]
C1527349
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0677898
UMLS CUI [4,3]
C2828389
UMLS CUI [4,4]
C0023434
UMLS CUI [4,5]
C0441763
Does the participant have uncontrolled systemic disease, including known human immunodeficiency virus (hiv) positive patients?
Beschreibung

Uncontrolled systemic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1512693
UMLS CUI [1,4]
C0019699
Does the participant have a history of congestive heart failure?
Beschreibung

Congestive Heart Failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018802
Does the participant have clinically important history of liver disease, including viral or hepatitis, current alcohol abuse, or cirrhosis?
Beschreibung

Relevant Liver Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0023895
UMLS CUI [1,3]
C3898777
UMLS CUI [1,4]
C1512693
UMLS CUI [1,5]
C0019158
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0023895
UMLS CUI [2,3]
C3898777
UMLS CUI [2,4]
C1512693
UMLS CUI [2,5]
C0042721
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0023895
UMLS CUI [3,3]
C3898777
UMLS CUI [3,4]
C1512693
UMLS CUI [3,5]
C0521116
UMLS CUI [3,6]
C0085762
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0023895
UMLS CUI [4,3]
C3898777
UMLS CUI [4,4]
C1512693
UMLS CUI [4,5]
C1623038
Does the participant have any condition or situation which in the investigator's opinion may put the patient at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study; this includes history of other skin conditions or disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications?
Beschreibung

Patient unfit for study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0871010
UMLS CUI [1,4]
C0035647
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0008961
UMLS CUI [2,3]
C0871010
UMLS CUI [2,4]
C0009673
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0008961
UMLS CUI [3,3]
C0871010
UMLS CUI [3,4]
C0521102
UMLS CUI [3,5]
C2348568
UMLS CUI [4,1]
C1512693
UMLS CUI [4,2]
C1719933
UMLS CUI [5]
C2362507
UMLS CUI [6]
C0031809
UMLS CUI [7]
C4505474
UMLS CUI [8,1]
C0522473
UMLS CUI [8,2]
C0013230
UMLS CUI [9,1]
C0392760
UMLS CUI [9,2]
C0459471
UMLS CUI [9,3]
C0683954
UMLS CUI [10,1]
C0332167
UMLS CUI [10,2]
C0679861
Does the participant have a history of hypersensitivity to any of the ingredients in the study medication formulations?
Beschreibung

Hypersensitivity to study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0085993
UMLS CUI [1,3]
C0013230
Is the participant willing to abstain from application of non-study topical medications to the skin for the duration of the study, including prescription and over the counter preparations; for example, topical preparations containing corticosteroids or vitamin a derivatives are not allowed?
Beschreibung

Abstaining from topical drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C1705537
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C1522168
UMLS CUI [1,5]
C0347984
UMLS CUI [1,6]
C0008976
UMLS CUI [2]
C0304604
UMLS CUI [3]
C3892279
Is the patient pregnant or nursing?
Beschreibung

Pregnant or Nursing

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Basal cell carcinoma
Item
Does the participant have at least one BCC, > 5 mm, eligible for Mohs surgical removal? (participants with BCCs that have been treated before (recurrent bccs, bccs that failed other chemotherapy) are eligible for this trial, if they meet size criteria)
boolean
C0007117 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0079850 (UMLS CUI [1,3])
C0007117 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
C1548635 (UMLS CUI [2,4])
C0243161 (UMLS CUI [2,5])
C0456389 (UMLS CUI [2,6])
C0007117 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C3665472 (UMLS CUI [3,3])
C0231175 (UMLS CUI [3,4])
C1548635 (UMLS CUI [3,5])
C0243161 (UMLS CUI [3,6])
C0456389 (UMLS CUI [3,7])
Performance Status
Item
Will no eastern cooperative oncology group (ecog) or karnofsky performance status be employed?
boolean
C0445107 (UMLS CUI [1,1])
C3541269 (UMLS CUI [1,2])
C0445107 (UMLS CUI [2,1])
C0206065 (UMLS CUI [2,2])
Hepatic function
Item
Does the participant have normal hepatic function: aspartate aminotransferase (ast) and alanine aminotransferase (alt) =< 2 x the upper limit of normal (uln)?
boolean
C0232741 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
Renal function
Item
Does the participant have normal renal function : normal serum creatinine defined as <= 2.5 mg/dl?
boolean
C0232804 (UMLS CUI [1,1])
C0600061 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Complete Blood Count
Item
Does the participant have a clinically acceptable complete blood count (cbc)?
boolean
C0009555 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Informed consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C1273101 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0600109 (UMLS CUI [2,1])
C0742766 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Willingness for Surgical Treatment
Item
Is the participant willing to forego surgical treatment of bccs by up to 6 months, except when the principal investigator (pi) believes that delay in treatment potentially might compromise the health of the subject?
boolean
C0600109 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0007117 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,4])
C1521895 (UMLS CUI [1,5])
C0004951 (UMLS CUI [1,6])
C0522486 (UMLS CUI [1,7])
C2945640 (UMLS CUI [1,8])
C0018684 (UMLS CUI [1,9])
Negative pregancy test and contraception
Item
Does the participant have documented negative serum pregnancy test for women of childbearing potential, with agreement to the use of two acceptable methods of contraception during the study and for 7 months after discontinuation of vismodegib?
boolean
C1301725 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C4324275 (UMLS CUI [1,3])
C0004764 (UMLS CUI [1,4])
C0439064 (UMLS CUI [1,5])
C0347984 (UMLS CUI [1,6])
C0008976 (UMLS CUI [1,7])
C1948053 (UMLS CUI [1,8])
C0687676 (UMLS CUI [1,9])
C4288399 (UMLS CUI [1,10])
Male contraception
Item
for men with female partners of childbearing potential, agreement to use a latex, non-latex, or any other male condom and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug
boolean
C0009653 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0043210 (UMLS CUI [1,3])
C1524062 (UMLS CUI [1,4])
C0700589 (UMLS CUI [1,5])
C0347984 (UMLS CUI [1,6])
C0008976 (UMLS CUI [1,7])
C1948053 (UMLS CUI [1,8])
C0687676 (UMLS CUI [1,9])
C4288399 (UMLS CUI [1,10])
No Blood or Semen donations
Item
Is the participant willing to not donate blood or semen for three months following discontinuation of study medications?
boolean
C0600109 (UMLS CUI [1,1])
C3840725 (UMLS CUI [1,2])
C0871414 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
C0687676 (UMLS CUI [1,5])
C4288399 (UMLS CUI [1,6])
C0600109 (UMLS CUI [2,1])
C3840725 (UMLS CUI [2,2])
C0005794 (UMLS CUI [2,3])
C1948053 (UMLS CUI [2,4])
C0687676 (UMLS CUI [2,5])
C4288399 (UMLS CUI [2,6])
Item Group
C0680251 (UMLS CUI)
History of invasive cancer
Item
Does the participant have a history of invasive cancer within the past five years excluding non-melanoma skin cancer, stage i cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (cll) stage 0?
boolean
C0262926 (UMLS CUI [1,1])
C0677898 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0007114 (UMLS CUI [1,4])
C0332288 (UMLS CUI [1,5])
C0025202 (UMLS CUI [1,6])
C0262926 (UMLS CUI [2,1])
C0677898 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0278575 (UMLS CUI [2,4])
C0262926 (UMLS CUI [3,1])
C0677898 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
C1527349 (UMLS CUI [3,4])
C0262926 (UMLS CUI [4,1])
C0677898 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
C0023434 (UMLS CUI [4,4])
C0441763 (UMLS CUI [4,5])
Uncontrolled systemic disease
Item
Does the participant have uncontrolled systemic disease, including known human immunodeficiency virus (hiv) positive patients?
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0019699 (UMLS CUI [1,4])
Congestive Heart Failure
Item
Does the participant have a history of congestive heart failure?
boolean
C0262926 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
Relevant Liver Disease
Item
Does the participant have clinically important history of liver disease, including viral or hepatitis, current alcohol abuse, or cirrhosis?
boolean
C0262926 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C3898777 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,4])
C0019158 (UMLS CUI [1,5])
C0262926 (UMLS CUI [2,1])
C0023895 (UMLS CUI [2,2])
C3898777 (UMLS CUI [2,3])
C1512693 (UMLS CUI [2,4])
C0042721 (UMLS CUI [2,5])
C0262926 (UMLS CUI [3,1])
C0023895 (UMLS CUI [3,2])
C3898777 (UMLS CUI [3,3])
C1512693 (UMLS CUI [3,4])
C0521116 (UMLS CUI [3,5])
C0085762 (UMLS CUI [3,6])
C0262926 (UMLS CUI [4,1])
C0023895 (UMLS CUI [4,2])
C3898777 (UMLS CUI [4,3])
C1512693 (UMLS CUI [4,4])
C1623038 (UMLS CUI [4,5])
Patient unfit for study
Item
Does the participant have any condition or situation which in the investigator's opinion may put the patient at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study; this includes history of other skin conditions or disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications?
boolean
C0348080 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0871010 (UMLS CUI [1,3])
C0035647 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
C0871010 (UMLS CUI [2,3])
C0009673 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0008961 (UMLS CUI [3,2])
C0871010 (UMLS CUI [3,3])
C0521102 (UMLS CUI [3,4])
C2348568 (UMLS CUI [3,5])
C1512693 (UMLS CUI [4,1])
C1719933 (UMLS CUI [4,2])
C2362507 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
C4505474 (UMLS CUI [7])
C0522473 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C0392760 (UMLS CUI [9,1])
C0459471 (UMLS CUI [9,2])
C0683954 (UMLS CUI [9,3])
C0332167 (UMLS CUI [10,1])
C0679861 (UMLS CUI [10,2])
Hypersensitivity to study medication
Item
Does the participant have a history of hypersensitivity to any of the ingredients in the study medication formulations?
boolean
C0020517 (UMLS CUI [1,1])
C0085993 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Abstaining from topical drugs
Item
Is the participant willing to abstain from application of non-study topical medications to the skin for the duration of the study, including prescription and over the counter preparations; for example, topical preparations containing corticosteroids or vitamin a derivatives are not allowed?
boolean
C0600109 (UMLS CUI [1,1])
C1705537 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C1522168 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,6])
C0304604 (UMLS CUI [2])
C3892279 (UMLS CUI [3])
Pregnant or Nursing
Item
Is the patient pregnant or nursing?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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