ID

34861

Description

An Observational Study to Determine the Clinical Cure Rate of Therapeutic up Front Shave Removal of Basal Cell Carcinoma of the Skin With Long Term Follow up to Evaluate Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT02296970

Link

https://clinicaltrials.gov/show/NCT02296970

Keywords

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

See clinicaltrials.gov

Uploaded on

February 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Basal Cell Carcinoma NCT02296970

English

Eligibility Basal Cell Carcinoma NCT02296970

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 18 years or older that are determined by an investigator to have a lesion that is highly likely to be a bcc, less than or equal to 1.0cm in largest diameter, based on clinical examination located in the trunk or extremities, proximal to the wrist and ankles
Description

Age | Lesion Very likely Basal cell carcinoma | Lesion Diameter Largest | Location of lesion Trunk | Location of lesion Extremities Proximal Wrist | Location of lesion Extremities Proximal Ankle

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C3840799
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0443228
UMLS CUI [4,1]
C2184261
UMLS CUI [4,2]
C0460005
UMLS CUI [5,1]
C2184261
UMLS CUI [5,2]
C0015385
UMLS CUI [5,3]
C0205107
UMLS CUI [5,4]
C0043262
UMLS CUI [6,1]
C2184261
UMLS CUI [6,2]
C0015385
UMLS CUI [6,3]
C0205107
UMLS CUI [6,4]
C0003086
subject is able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subject is able to commit to 6 month follow up visit
Description

Follow-up Duration Commitment

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0870312
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bcc > 1cm in diameter on any one axis.
Description

Basal cell carcinoma Diameter Axis Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1522496
UMLS CUI [1,4]
C1552551
immunosuppressed patients
Description

Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
subjects with neutropenia
Description

Neutropenia

Data type

boolean

Alias
UMLS CUI [1]
C0027947
organ transplant patients
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
subjects with a life expectancy less than year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients taking immunosuppressive medications, including prednisone at a dose of 10mg or greater with an expected duration greater than 4 weeks, azathioprine, mycophenolate mofetil, cyclosporine, oral tacrolimus, any tumor necrosis factor (tnf)-alpha inhibitor, ustekinumab, rituximab, or any other medication in the judgement of the investigator could results in clinically meaningful immunosuppression of the subject
Description

Immunosuppressive Agents | Prednisone Dosage | Azathioprine | mycophenolate mofetil | Cyclosporine | Tacrolimus Oral Product | TNF-alpha inhibitor | ustekinumab | rituximab

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0178602
UMLS CUI [3]
C0004482
UMLS CUI [4]
C0209368
UMLS CUI [5]
C0010592
UMLS CUI [6]
C1273163
UMLS CUI [7]
C1562242
UMLS CUI [8]
C1608841
UMLS CUI [9]
C0393022
basal cell carcinomas that have infiltrative or morpheaform characteristics based on clinical examination
Description

Basal cell carcinoma infiltrative Clinical examination | Morpheic basal cell carcinoma Clinical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1304298
UMLS CUI [1,2]
C1456356
UMLS CUI [2,1]
C0555191
UMLS CUI [2,2]
C1456356
subjects unable to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
subjects unable to commit to 6 month follow up
Description

Follow-up Duration Commitment Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0870312
UMLS CUI [1,4]
C1299582
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Similar models

Eligibility Basal Cell Carcinoma NCT02296970

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Lesion Very likely Basal cell carcinoma | Lesion Diameter Largest | Location of lesion Trunk | Location of lesion Extremities Proximal Wrist | Location of lesion Extremities Proximal Ankle
Item
patients 18 years or older that are determined by an investigator to have a lesion that is highly likely to be a bcc, less than or equal to 1.0cm in largest diameter, based on clinical examination located in the trunk or extremities, proximal to the wrist and ankles
boolean
C0001779 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C3840799 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0443228 (UMLS CUI [3,3])
C2184261 (UMLS CUI [4,1])
C0460005 (UMLS CUI [4,2])
C2184261 (UMLS CUI [5,1])
C0015385 (UMLS CUI [5,2])
C0205107 (UMLS CUI [5,3])
C0043262 (UMLS CUI [5,4])
C2184261 (UMLS CUI [6,1])
C0015385 (UMLS CUI [6,2])
C0205107 (UMLS CUI [6,3])
C0003086 (UMLS CUI [6,4])
Informed Consent
Item
subject is able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Follow-up Duration Commitment
Item
subject is able to commit to 6 month follow up visit
boolean
C3274571 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0870312 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Basal cell carcinoma Diameter Axis Any
Item
bcc > 1cm in diameter on any one axis.
boolean
C0007117 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1522496 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,4])
Therapeutic immunosuppression
Item
immunosuppressed patients
boolean
C0021079 (UMLS CUI [1])
Neutropenia
Item
subjects with neutropenia
boolean
C0027947 (UMLS CUI [1])
Organ Transplantation
Item
organ transplant patients
boolean
C0029216 (UMLS CUI [1])
Life Expectancy
Item
subjects with a life expectancy less than year
boolean
C0023671 (UMLS CUI [1])
Immunosuppressive Agents | Prednisone Dosage | Azathioprine | mycophenolate mofetil | Cyclosporine | Tacrolimus Oral Product | TNF-alpha inhibitor | ustekinumab | rituximab
Item
patients taking immunosuppressive medications, including prednisone at a dose of 10mg or greater with an expected duration greater than 4 weeks, azathioprine, mycophenolate mofetil, cyclosporine, oral tacrolimus, any tumor necrosis factor (tnf)-alpha inhibitor, ustekinumab, rituximab, or any other medication in the judgement of the investigator could results in clinically meaningful immunosuppression of the subject
boolean
C0021081 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0004482 (UMLS CUI [3])
C0209368 (UMLS CUI [4])
C0010592 (UMLS CUI [5])
C1273163 (UMLS CUI [6])
C1562242 (UMLS CUI [7])
C1608841 (UMLS CUI [8])
C0393022 (UMLS CUI [9])
Basal cell carcinoma infiltrative Clinical examination | Morpheic basal cell carcinoma Clinical examination
Item
basal cell carcinomas that have infiltrative or morpheaform characteristics based on clinical examination
boolean
C1304298 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
C0555191 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Informed Consent Unable
Item
subjects unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Follow-up Duration Commitment Unable
Item
subjects unable to commit to 6 month follow up
boolean
C3274571 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0870312 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
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