ID

42488

Beschreibung

Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC); ODM derived from: https://clinicaltrials.gov/show/NCT01808950

Link

https://clinicaltrials.gov/show/NCT01808950

Stichworte

Versionen (1)
  1. 28.07.21 28.07.21 -
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Spirig Pharma Ltd.

Hochgeladen am

28. Juli 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Nodular Basal Cell Carcinoma NCT01808950

Englisch

Eligibility Nodular Basal Cell Carcinoma NCT01808950

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed consent form.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
male or non-pregnant, non-lactating female, ≥ 18 years.
Beschreibung

Gender | Non-pregnant | Non-lactating female | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0001779
must have a previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.
Beschreibung

Previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1304300
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0475264
UMLS CUI [1,4]
C0460004
UMLS CUI [2,1]
C1304300
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0475264
UMLS CUI [2,4]
C0460005
UMLS CUI [3,1]
C1304300
UMLS CUI [3,2]
C0332155
UMLS CUI [3,3]
C0475264
UMLS CUI [3,4]
C1140618
nbcc must not be larger than 20 mm in diameter and must be less than 5 mm in depth.
Beschreibung

Nbcc | Diameter | Depth

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1304300
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0205125
willing and able to participate in the trial as an outpatient and comply with all trial requirements.
Beschreibung

Willing and able to participate as as outpatient, protocol compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0085732
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
nbcc located close to or at mouth or eyes.
Beschreibung

Nbcc located close to or at mouth or eyes.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1304300
UMLS CUI [1,2]
C0475264
UMLS CUI [1,3]
C1706276
UMLS CUI [1,4]
C0015392
UMLS CUI [2,1]
C1304300
UMLS CUI [2,2]
C0475264
UMLS CUI [2,3]
C0230028
patients who have had an organ transplant.
Beschreibung

Organ transplant recipient

Datentyp

boolean

Alias
UMLS CUI [1]
C0376387
known autoimmune disorder (especially psoriasis), impaired immune system (e.g. hiv), known thyroid abnormalities, known depression.
Beschreibung

Autoimmune disorder | Immunosuppression | Thyroid abnormalities | Depression

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C4048329
UMLS CUI [3]
C0040128
UMLS CUI [4]
C0011581
an open wound or an infection in treatment area.
Beschreibung

An open wound or an infection in treatment area.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332798
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205146
UMLS CUI [2,1]
C3714514
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205146
dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments.
Beschreibung

Dermatological disease in the treatment or surrounding area | Other condition in the area that might impair trial assessments.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205146
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205146
UMLS CUI [2,4]
C0332149
UMLS CUI [2,5]
C0392760
UMLS CUI [2,6]
C0008976
evidence of an active infection or systemic cancer.
Beschreibung

Active infection | Malignant neoplasm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [2]
C0006826
flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial.
Beschreibung

Flu recent | Flu-like symptoms recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021400
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0392171
UMLS CUI [2,2]
C0332185
known allergy or hypersensitivity to any of the trial gel ingredients.
Beschreibung

Medical history of hypersentitivity to any of the trial gel ingredients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C1550600
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0017243
evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease).
Beschreibung

Unstable or uncontrolled clinically significant medical conditions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2826293
current alcohol abuse or chemical dependency as assessed by the investigator.
Beschreibung

Current alcohol abuse | Current chemical dependency

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0521116
patient who is detained or committed to an institution by a law court or by legal authorities.
Beschreibung

Institutionalized persons

Datentyp

boolean

Alias
UMLS CUI [1]
C0376326
participation in another clinical trial within one month before start of the trial.
Beschreibung

Study subject partitipation status, recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332185
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Ähnliche Modelle

Eligibility Nodular Basal Cell Carcinoma NCT01808950

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
signed consent form.
boolean
C0021430 (UMLS CUI [1])
Gender | Non-pregnant | Non-lactating female | Age
Item
male or non-pregnant, non-lactating female, ≥ 18 years.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.
Item
must have a previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.
boolean
C1304300 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
C0460004 (UMLS CUI [1,4])
C1304300 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0475264 (UMLS CUI [2,3])
C0460005 (UMLS CUI [2,4])
C1304300 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0475264 (UMLS CUI [3,3])
C1140618 (UMLS CUI [3,4])
Nbcc | Diameter | Depth
Item
nbcc must not be larger than 20 mm in diameter and must be less than 5 mm in depth.
boolean
C1304300 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,3])
Willing and able to participate as as outpatient, protocol compliance
Item
willing and able to participate in the trial as an outpatient and comply with all trial requirements.
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Nbcc located close to or at mouth or eyes.
Item
nbcc located close to or at mouth or eyes.
boolean
C1304300 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C1706276 (UMLS CUI [1,3])
C0015392 (UMLS CUI [1,4])
C1304300 (UMLS CUI [2,1])
C0475264 (UMLS CUI [2,2])
C0230028 (UMLS CUI [2,3])
Organ transplant recipient
Item
patients who have had an organ transplant.
boolean
C0376387 (UMLS CUI [1])
Autoimmune disorder | Immunosuppression | Thyroid abnormalities | Depression
Item
known autoimmune disorder (especially psoriasis), impaired immune system (e.g. hiv), known thyroid abnormalities, known depression.
boolean
C0004364 (UMLS CUI [1])
C4048329 (UMLS CUI [2])
C0040128 (UMLS CUI [3])
C0011581 (UMLS CUI [4])
An open wound or an infection in treatment area.
Item
an open wound or an infection in treatment area.
boolean
C0332798 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C3714514 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205146 (UMLS CUI [2,3])
Dermatological disease in the treatment or surrounding area | Other condition in the area that might impair trial assessments.
Item
dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments.
boolean
C0037274 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205146 (UMLS CUI [2,3])
C0332149 (UMLS CUI [2,4])
C0392760 (UMLS CUI [2,5])
C0008976 (UMLS CUI [2,6])
Active infection | Malignant neoplasm
Item
evidence of an active infection or systemic cancer.
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
Flu recent | Flu-like symptoms recent
Item
flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial.
boolean
C0021400 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0392171 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Medical history of hypersentitivity to any of the trial gel ingredients
Item
known allergy or hypersensitivity to any of the trial gel ingredients.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0017243 (UMLS CUI [1,5])
Unstable or uncontrolled clinically significant medical conditions
Item
evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Current alcohol abuse | Current chemical dependency
Item
current alcohol abuse or chemical dependency as assessed by the investigator.
boolean
C0085762 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Institutionalized persons
Item
patient who is detained or committed to an institution by a law court or by legal authorities.
boolean
C0376326 (UMLS CUI [1])
Study subject partitipation status, recent
Item
participation in another clinical trial within one month before start of the trial.
boolean
C2348568 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
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