ID

15916

Beschreibung

Safety and Efficacy Study of Imiquimod 5% Cream Applied 3x Per Week for 8 or 12 Weeks in Low Risk Nodular Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00204555

Link

https://clinicaltrials.gov/show/NCT00204555

Stichworte

Versionen (3)
  1. 03.06.16 03.06.16 -
  2. 05.06.16 05.06.16 -
  3. 18.06.16 18.06.16 -
Hochgeladen am

18. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Basal Cell NCT00204555

Englisch

Eligibility Carcinoma, Basal Cell NCT00204555

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are able to understand and willing to give informed consent prior to study procedures
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
age 18+
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
have one bcc which meets the following criteria: a primary tumor (not recurrent, not previously biopsied or treated; non-infected; located on the limbs, trunk (anogenital area excluded), neck, or head. the target tumor must be visible; maximum tumor area of 1.5 cm in diameter; macroscopically (clinically) consistent with nodular bcc; nodular subtype, with circumscribed growth pattern; histologically consistent with nbcc, and having no histological evidence of aggressive growth patterns; easily identifiable and treatable by subject or reliable subject representative;
Beschreibung

basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1304300
UMLS CUI [1,2]
C1306459
UMLS CUI [1,3]
C1551402
UMLS CUI [1,4]
C0015385
UMLS CUI [2]
C0460004
UMLS CUI [3]
C0460005
are willing and able to participate in the study as an outpatient, making necessary visits to the clinic during the treatment period and comply with study requirements, including the following: a minimum of 1 and a maximum of 3 prestudy confirmatory biopsies of different tumors before beginning study drug treatment (each biopsy will remove no more than 25% of the target tumor); at least 4 or 5 clinic visits during the study; blood sampling at screening/initiation visit and end of treatment; urine pregnancy testing for females of childbearing potential at the screening/initiation visit and the end of treatment visits
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
are free of any significant physical abnormalities at the potential application site area, which would interfere with assessment of possible site reactions (eg, eczema, psoriasis, tattoos)
Beschreibung

physical abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0037268
UMLS CUI [2]
C0009488
if female and of childbearing potential, has negative urine pregnancy tests during screening/initiation visit, and is willing to use a medically acceptable method of contraception during the treatment period
Beschreibung

pregnancy test and contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0009905
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
high-risk areas within 0.5 cm of the eyes
Beschreibung

high-risk areas of the eyes

Datentyp

boolean

have evidence of clinically significant, unstable medical conditions such as metastatic tumor or tumor with high probability of metastatic spread, cardiovascular (nyha class iii, iv), immunomodulation or immunosuppressive therapies, hematologic, hepatic, renal, neurologic, endocrine, collagen-vascular, gastrointestinal
Beschreibung

significant comorbidities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0007226
UMLS CUI [3]
C1963758
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0205488
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0205054
UMLS CUI [6]
C0009488
have or had other malignant tumors of the skin within the target tumor site or surrounding area (eg, malignant melanoma, epithelioma spinocellular, squamous cell carcinoma). the surrounding area includes the skin within 2 cm of the target site margins in all directions
Beschreibung

other malignant tumors of the skin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0153538
UMLS CUI [1,2]
C0475445
have received the following treatments for any indication in the target tumor site or surrounding area within the designated time period (6 weeks) before treatment initiation: topical retinoids, topical steroids, surgical excision, curettage, cryo-, thermo- or chemodestruction, photodynamic therapy, therapeutic uv-radiation
Beschreibung

pre-treatment in targeted tumor site

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035339
UMLS CUI [1,2]
C1522168
UMLS CUI [2]
C2064827
UMLS CUI [3]
C0728940
UMLS CUI [4]
C0010468
UMLS CUI [5]
C0191455
UMLS CUI [6]
C0150611
UMLS CUI [7]
C0392920
UMLS CUI [8]
C1998192
UMLS CUI [9]
C0041626
have received the following systemic treatments within the designated period before study treatment initiation: interferon (6 weeks), immunomodulators or immunosuppressive therapies (10 weeks), cytotoxic drugs (6 months), investigational drugs (8 weeks), drugs known to have major organ toxicity (8 weeks), corticosteroids (oral or injectable) (6 weeks), inhaled corticosteroids (>1200 ng/day for beclomethasone, or >600 ng/day for fluticasone)(4 weeks)
Beschreibung

systemic pre-treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0279030
UMLS CUI [2]
C1527392
UMLS CUI [3]
C0021079
UMLS CUI [4]
C0304497
UMLS CUI [5]
C0013230
UMLS CUI [6]
C0001617
UMLS CUI [7]
C2065041
have received any systemic cancer chemotherapy within 6 months before study treatment initiation
Beschreibung

prior cancer chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C3828652
have known allergies to any excipient in the study cream (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan monostearate, white petrolatum, glycerin, methyl paraben, propyl paraben, purified water, and xanthan gum
Beschreibung

hypersensitivity to study cream

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0244561
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0005100
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0055152
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0075206
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0982351
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0074915
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0031262
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0017861
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0066415
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0072238
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0991883
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0078596
are known to be pregnant or lactating (currently or within the past 3 months). if the subject was pregnant, at least 3 months must have elapsed since parturition or termination
Beschreibung

pregnant or lactating

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
have any dermatological disease in the target tumor site or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (eg psoriasis, eczema)
Beschreibung

dermatological disease in the target tumor site

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0037274
are currently or within the past 8 weeks participating in another clinical study
Beschreibung

participating in another clinical study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
have active chemical dependency or alcoholism as assessed by the investigator
Beschreibung

substance use disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
have had a systemic bacterial or viral infection within 2 weeks prior to study initiation
Beschreibung

systemic bacterial or viral infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
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Ähnliche Modelle

Eligibility Carcinoma, Basal Cell NCT00204555

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
patients who are able to understand and willing to give informed consent prior to study procedures
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
age
Item
age 18+
boolean
C0001779 (UMLS CUI [1])
basal cell carcinoma
Item
have one bcc which meets the following criteria: a primary tumor (not recurrent, not previously biopsied or treated; non-infected; located on the limbs, trunk (anogenital area excluded), neck, or head. the target tumor must be visible; maximum tumor area of 1.5 cm in diameter; macroscopically (clinically) consistent with nodular bcc; nodular subtype, with circumscribed growth pattern; histologically consistent with nbcc, and having no histological evidence of aggressive growth patterns; easily identifiable and treatable by subject or reliable subject representative;
boolean
C1304300 (UMLS CUI [1,1])
C1306459 (UMLS CUI [1,2])
C1551402 (UMLS CUI [1,3])
C0015385 (UMLS CUI [1,4])
C0460004 (UMLS CUI [2])
C0460005 (UMLS CUI [3])
informed consent
Item
are willing and able to participate in the study as an outpatient, making necessary visits to the clinic during the treatment period and comply with study requirements, including the following: a minimum of 1 and a maximum of 3 prestudy confirmatory biopsies of different tumors before beginning study drug treatment (each biopsy will remove no more than 25% of the target tumor); at least 4 or 5 clinic visits during the study; blood sampling at screening/initiation visit and end of treatment; urine pregnancy testing for females of childbearing potential at the screening/initiation visit and the end of treatment visits
boolean
C0021430 (UMLS CUI [1])
physical abnormalities
Item
are free of any significant physical abnormalities at the potential application site area, which would interfere with assessment of possible site reactions (eg, eczema, psoriasis, tattoos)
boolean
C0037268 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
pregnancy test and contraception
Item
if female and of childbearing potential, has negative urine pregnancy tests during screening/initiation visit, and is willing to use a medically acceptable method of contraception during the treatment period
boolean
C0032961 (UMLS CUI [1,1])
C0009905 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
high-risk areas of the eyes
Item
high-risk areas within 0.5 cm of the eyes
boolean
significant comorbidities
Item
have evidence of clinically significant, unstable medical conditions such as metastatic tumor or tumor with high probability of metastatic spread, cardiovascular (nyha class iii, iv), immunomodulation or immunosuppressive therapies, hematologic, hepatic, renal, neurologic, endocrine, collagen-vascular, gastrointestinal
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0007226 (UMLS CUI [2,2])
C1963758 (UMLS CUI [3])
C0009488 (UMLS CUI [4,1])
C0205488 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5,1])
C0205054 (UMLS CUI [5,2])
C0009488 (UMLS CUI [6])
other malignant tumors of the skin
Item
have or had other malignant tumors of the skin within the target tumor site or surrounding area (eg, malignant melanoma, epithelioma spinocellular, squamous cell carcinoma). the surrounding area includes the skin within 2 cm of the target site margins in all directions
boolean
C0153538 (UMLS CUI [1,1])
C0475445 (UMLS CUI [1,2])
pre-treatment in targeted tumor site
Item
have received the following treatments for any indication in the target tumor site or surrounding area within the designated time period (6 weeks) before treatment initiation: topical retinoids, topical steroids, surgical excision, curettage, cryo-, thermo- or chemodestruction, photodynamic therapy, therapeutic uv-radiation
boolean
C0035339 (UMLS CUI [1,1])
C1522168 (UMLS CUI [1,2])
C2064827 (UMLS CUI [2])
C0728940 (UMLS CUI [3])
C0010468 (UMLS CUI [4])
C0191455 (UMLS CUI [5])
C0150611 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
C1998192 (UMLS CUI [8])
C0041626 (UMLS CUI [9])
systemic pre-treatment
Item
have received the following systemic treatments within the designated period before study treatment initiation: interferon (6 weeks), immunomodulators or immunosuppressive therapies (10 weeks), cytotoxic drugs (6 months), investigational drugs (8 weeks), drugs known to have major organ toxicity (8 weeks), corticosteroids (oral or injectable) (6 weeks), inhaled corticosteroids (>1200 ng/day for beclomethasone, or >600 ng/day for fluticasone)(4 weeks)
boolean
C0279030 (UMLS CUI [1])
C1527392 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
C0304497 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
C0001617 (UMLS CUI [6])
C2065041 (UMLS CUI [7])
prior cancer chemotherapy
Item
have received any systemic cancer chemotherapy within 6 months before study treatment initiation
boolean
C0392920 (UMLS CUI [1,1])
C3828652 (UMLS CUI [1,2])
hypersensitivity to study cream
Item
have known allergies to any excipient in the study cream (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan monostearate, white petrolatum, glycerin, methyl paraben, propyl paraben, purified water, and xanthan gum
boolean
C0020517 (UMLS CUI [1,1])
C0244561 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0005100 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0055152 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0075206 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0982351 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0074915 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0031262 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0017861 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0066415 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0072238 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0991883 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C0078596 (UMLS CUI [12,2])
pregnant or lactating
Item
are known to be pregnant or lactating (currently or within the past 3 months). if the subject was pregnant, at least 3 months must have elapsed since parturition or termination
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
dermatological disease in the target tumor site
Item
have any dermatological disease in the target tumor site or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (eg psoriasis, eczema)
boolean
C0009488 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
participating in another clinical study
Item
are currently or within the past 8 weeks participating in another clinical study
boolean
C2348568 (UMLS CUI [1])
substance use disorder
Item
have active chemical dependency or alcoholism as assessed by the investigator
boolean
C0038586 (UMLS CUI [1])
systemic bacterial or viral infection
Item
have had a systemic bacterial or viral infection within 2 weeks prior to study initiation
boolean
C0009450 (UMLS CUI [1])
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