ID

14892

Description

One-stop-shop Study for Treatment of Basal Cell Carcinoma Using Reflectance Confocal Microscopy; ODM derived from: https://clinicaltrials.gov/show/NCT02285790

Link

https://clinicaltrials.gov/show/NCT02285790

Keywords

Versions (1)
  1. 5/4/16 5/4/16 -
Uploaded on

May 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Basal Cell NCT02285790

English

Eligibility Carcinoma, Basal Cell NCT02285790

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with clinically suspected new primary bcc as assessed by an experienced board certified dermatologist
Description

Basal cell carcinoma - primary

Data type

boolean

Alias
UMLS CUI [1]
C1304305
patients seen at the outpatient clinic before 12h00 am will be eligible to participate
Description

Ambulatory Care Facilities | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0002424
UMLS CUI [2]
C2348568
patient is willing and able to give written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
bcc lesion is suitable for conventional surgical excision under local anesthetics
Description

Basal cell carcinoma Lesion | Excision | Local Anesthetics

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C0728940
UMLS CUI [3]
C0002934
bcc lesion is present since at least 1 month
Description

Basal cell carcinoma Lesion Present

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0150312
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bcc lesion in a high-risk location of the face (h-zone and ears)
Description

Basal cell carcinoma Lesion | H zone | Entire ear

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C0230717
UMLS CUI [3]
C0521421
contra-indication for conventional surgical excision (primary surgical closure seems not achievable)
Description

Medical contraindication Excision | Reparative closure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728940
UMLS CUI [2]
C0185003
recurrent bcc lesion (bcc that has been previously unsuccessfully treated) macroscopic ulcerating bcc lesions (not feasible for rcm analysis due to technical reasons)
Description

Basal cell carcinoma Lesion Recurrent | Basal cell carcinoma Lesion Ulceration Gross

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C2945760
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C3887532
UMLS CUI [2,4]
C0439806
patients with basal cell nevus syndrome
Description

Basal Cell Nevus Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0004779
patients treated with hedgehog inhibitor medication
Description

Therapeutic procedure Hedgehog Pathway Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3267924
patients with a history of hypersensitivity to and/ or a history of allergy to local anesthesia
Description

Hypersensitivity Local anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002921
unavailability within the following 6 weeks (for example due to holiday or sports)
Description

Patient unavailable Due to Holidays | Patient unavailable Due to Sports

Data type

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019843
UMLS CUI [2,1]
C1301818
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0038039
patients not competent to understand the procedures involved
Description

Unable Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C2348563
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Similar models

Eligibility Carcinoma, Basal Cell NCT02285790

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Basal cell carcinoma - primary
Item
patients with clinically suspected new primary bcc as assessed by an experienced board certified dermatologist
boolean
C1304305 (UMLS CUI [1])
Ambulatory Care Facilities | Study Subject Participation Status
Item
patients seen at the outpatient clinic before 12h00 am will be eligible to participate
boolean
C0002424 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Informed Consent
Item
patient is willing and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Basal cell carcinoma Lesion | Excision | Local Anesthetics
Item
bcc lesion is suitable for conventional surgical excision under local anesthetics
boolean
C0007117 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
C0002934 (UMLS CUI [3])
Basal cell carcinoma Lesion Present
Item
bcc lesion is present since at least 1 month
boolean
C0007117 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Basal cell carcinoma Lesion | H zone | Entire ear
Item
bcc lesion in a high-risk location of the face (h-zone and ears)
boolean
C0007117 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0230717 (UMLS CUI [2])
C0521421 (UMLS CUI [3])
Medical contraindication Excision | Reparative closure
Item
contra-indication for conventional surgical excision (primary surgical closure seems not achievable)
boolean
C1301624 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0185003 (UMLS CUI [2])
Basal cell carcinoma Lesion Recurrent | Basal cell carcinoma Lesion Ulceration Gross
Item
recurrent bcc lesion (bcc that has been previously unsuccessfully treated) macroscopic ulcerating bcc lesions (not feasible for rcm analysis due to technical reasons)
boolean
C0007117 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0007117 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C3887532 (UMLS CUI [2,3])
C0439806 (UMLS CUI [2,4])
Basal Cell Nevus Syndrome
Item
patients with basal cell nevus syndrome
boolean
C0004779 (UMLS CUI [1])
Therapeutic procedure Hedgehog Pathway Inhibitor
Item
patients treated with hedgehog inhibitor medication
boolean
C0087111 (UMLS CUI [1,1])
C3267924 (UMLS CUI [1,2])
Hypersensitivity Local anesthesia
Item
patients with a history of hypersensitivity to and/ or a history of allergy to local anesthesia
boolean
C0020517 (UMLS CUI [1,1])
C0002921 (UMLS CUI [1,2])
Patient unavailable Due to Holidays | Patient unavailable Due to Sports
Item
unavailability within the following 6 weeks (for example due to holiday or sports)
boolean
C1301818 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019843 (UMLS CUI [1,3])
C1301818 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0038039 (UMLS CUI [2,3])
Unable Comprehension Study Protocol
Item
patients not competent to understand the procedures involved
boolean
C1299582 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
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