ID

15582

Descripción

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

Palabras clave

Versiones (3)
  1. 3/6/16 3/6/16 -
  2. 5/6/16 5/6/16 -
  3. 18/6/16 18/6/16 -
Subido en

3 de junio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Eligibility Carcinoma, Basal Cell NCT00204555

Inglés

Eligibility Carcinoma, Basal Cell NCT00204555

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

ID.1

Tipo de datos

boolean

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

ID.2

Tipo de datos

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;
Descripción

ID.3

Tipo de datos

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
Descripción

ID.4

Tipo de datos

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)
Descripción

ID.5

Tipo de datos

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
Descripción

ID.6

Tipo de datos

boolean

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

Exclusion Criteria

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

ID.7

Tipo de datos

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
Descripción

ID.8

Tipo de datos

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
Descripción

ID.9

Tipo de datos

boolean

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
Descripción

ID.10

Tipo de datos

boolean

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)
Descripción

ID.11

Tipo de datos

boolean

have received any systemic cancer chemotherapy within 6 months before study treatment initiation
Descripción

ID.12

Tipo de datos

boolean

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
Descripción

ID.13

Tipo de datos

boolean

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
Descripción

ID.14

Tipo de datos

boolean

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)
Descripción

ID.15

Tipo de datos

boolean

are currently or within the past 8 weeks participating in another clinical study
Descripción

ID.16

Tipo de datos

boolean

have active chemical dependency or alcoholism as assessed by the investigator
Descripción

ID.17

Tipo de datos

boolean

have had a systemic bacterial or viral infection within 2 weeks prior to study initiation
Descripción

ID.18

Tipo de datos

boolean

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Similar models

Eligibility Carcinoma, Basal Cell NCT00204555

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
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])
ID.2
Item
age 18+
boolean
C0001779 (UMLS CUI [1])
ID.3
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])
ID.4
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])
ID.5
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])
ID.6
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)
ID.7
Item
high-risk areas within 0.5 cm of the eyes
boolean
ID.8
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])
ID.9
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
ID.10
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
ID.11
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
ID.12
Item
have received any systemic cancer chemotherapy within 6 months before study treatment initiation
boolean
ID.13
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
ID.14
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
ID.15
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
ID.16
Item
are currently or within the past 8 weeks participating in another clinical study
boolean
ID.17
Item
have active chemical dependency or alcoholism as assessed by the investigator
boolean
ID.18
Item
have had a systemic bacterial or viral infection within 2 weeks prior to study initiation
boolean
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