ID

11988

Description

Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL); ODM derived from: https://clinicaltrials.gov/show/NCT02192021

Link

https://clinicaltrials.gov/show/NCT02192021

Keywords

Versions (1)
  1. 8/30/15 8/30/15 -
Copyright Holder

ODM derived from: https://clinicaltrials.gov/show/NCT02192021

Uploaded on

August 30, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility ´T Cell Lymphoma NCT02192021

English

Eligibility Cutaneous T Cell Lymphoma NCT02192021

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

diagnosis of cutaneous t-cell lymphoma (ctcl) based upon a skin biopsy diagnostic of atypical epidermotropism of folliculocentric or epidermotropic t-cells.
Description

t-cell lymphoma; diagnosis; cutaneous; biopsy; skin

Data type

boolean

Alias
UMLS CUI [1]
C0079773
current stage of ia or ib.
Description

t stage; current

Data type

boolean

Alias
UMLS CUI [1]
C0677955
expected survival of greater than or equal to12 months.
Description

no code found

Data type

boolean

Alias
UMLS CUI [1]
C0038952
not be on any other investigational device/drug treatment.
Description

treatment; other; device; drug

Data type

boolean

Alias
UMLS CUI [1,1]
C2346570
UMLS CUI [1,2]
C0013230
have a sufficient number (i.e., n=4 for first dose cohort in initial safety evaluation; n=3 for remainder of subjects) and surface area (> 5 cm2) of ctcl patches or plaques for micro needle array-doxorubicin (mna-d) and micro needle array (mna) application.
Description

application; doxorubicin; initial; number; cohort; first; dose; area

Data type

boolean

Alias
UMLS CUI [1]
C0013089
willing to adhere to the instructions of the investigator and his research team and sign an informed consent form prior to entry into the study.
Description

informed consent; investigator; entry; study

Data type

boolean

Alias
UMLS CUI [1]
C0021430
have the following initial and subsequent pretreatment laboratory parameters: granulocytes ≥2,000/mm3; platelets >50,000/mm3; Serum creatinine level ≤2x the upper limit of normal (uln); ast, alt, , ldh, alk phos ≤3x the uln.subjects must be ³ 18 years of age and must be able to understand the written informed consent/assent document.
Description

upper limit of normal (sgpt); upper limit of normal (sgot); >= 18 years of age; informed consent; < 18 years of age; > 18 years of age; serum creatinine; granulocytes; platelets; laboratory; initial; ldh; ast; uln; alt

Data type

boolean

Alias
UMLS CUI [1]
C0018183
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0600061
UMLS CUI [4]
C0438236
have no evidence of active infection, regardless of the degree of severity or localization. subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. subjects on antibiotic therapy must be off antibiotics before beginning treatment.
Description

antibiotic therapy; active infections; evidence of; treatment; severity; complete; degree; study

Data type

boolean

Alias
UMLS CUI [1]
C0009450
not receive any other treatment for ctcl except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
Description

other treatment; anti-fungal; steroids; topical

Data type

boolean

Alias
UMLS CUI [1]
C2015819
willing to discontinue concomitant medications for ctcl for the duration of their study participation, including: high dose topical steroids - 2 week washout; oral steroids above 10 mg - 3 week washout; psoralen + ultraviolet a light (puva) or ultraviolet b light (uvb) (including sunbathing, tanning beds, etc.) - 2 week washout; extracorporeal photopheresis - 2 week washout; electron beam - 2 weeks washout; chemotherapeutic agents - 3 week washout; bexarotene capsules or other oral biologics - 2 week washout; and topical nitrogen mustard - 2 week washout.
Description

concomitant medications; chemotherapeutic agent; steroids; duration; capsules; electron; topical; agents; study; dose; high; oral; puva; week

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Exclusion Criteria
Description

Exclusion Criteria

Exclusion Criteria
Description

Exclusion Criteria

uncontrolled pain.
Description

pain

Data type

boolean

Alias
UMLS CUI [1]
C1557623
known history of autoimmune disease; or active hiv, htlv-1, and/or hepatitis infection.
Description

autoimmune disease; infection; hepatitis; active; hiv

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019682
pregnant or lactating.
Description

pregnant

Data type

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0549206
have sensitivity to drugs that provide local anesthesia.
Description

local anesthesia; drugs

Data type

boolean

Alias
UMLS CUI [1]
C0237865
have active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.
Description

carcinoma in situ; metastatic; prostate; exception; cervix; active; cancer; skin; non

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Cutaneous T Cell Lymphoma NCT02192021

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
t-cell lymphoma; diagnosis; cutaneous; biopsy; skin
Item
diagnosis of cutaneous t-cell lymphoma (ctcl) based upon a skin biopsy diagnostic of atypical epidermotropism of folliculocentric or epidermotropic t-cells.
boolean
C0079773 (UMLS CUI [1])
t stage; current
Item
current stage of ia or ib.
boolean
C0677955 (UMLS CUI [1])
no code found
Item
expected survival of greater than or equal to12 months.
boolean
C0038952 (UMLS CUI [1])
treatment; other; device; drug
Item
not be on any other investigational device/drug treatment.
boolean
C2346570 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
application; doxorubicin; initial; number; cohort; first; dose; area
Item
have a sufficient number (i.e., n=4 for first dose cohort in initial safety evaluation; n=3 for remainder of subjects) and surface area (> 5 cm2) of ctcl patches or plaques for micro needle array-doxorubicin (mna-d) and micro needle array (mna) application.
boolean
C0013089 (UMLS CUI [1])
informed consent; investigator; entry; study
Item
willing to adhere to the instructions of the investigator and his research team and sign an informed consent form prior to entry into the study.
boolean
C0021430 (UMLS CUI [1])
upper limit of normal (sgpt); upper limit of normal (sgot); >= 18 years of age; informed consent; < 18 years of age; > 18 years of age; serum creatinine; granulocytes; platelets; laboratory; initial; ldh; ast; uln; alt
Item
have the following initial and subsequent pretreatment laboratory parameters: granulocytes ≥2,000/mm3; platelets >50,000/mm3; Serum creatinine level ≤2x the upper limit of normal (uln); ast, alt, , ldh, alk phos ≤3x the uln.subjects must be ³ 18 years of age and must be able to understand the written informed consent/assent document.
boolean
C0018183 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0600061 (UMLS CUI [3])
C0438236 (UMLS CUI [4])
antibiotic therapy; active infections; evidence of; treatment; severity; complete; degree; study
Item
have no evidence of active infection, regardless of the degree of severity or localization. subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. subjects on antibiotic therapy must be off antibiotics before beginning treatment.
boolean
C0009450 (UMLS CUI [1])
other treatment; anti-fungal; steroids; topical
Item
not receive any other treatment for ctcl except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
boolean
C2015819 (UMLS CUI [1])
concomitant medications; chemotherapeutic agent; steroids; duration; capsules; electron; topical; agents; study; dose; high; oral; puva; week
Item
willing to discontinue concomitant medications for ctcl for the duration of their study participation, including: high dose topical steroids - 2 week washout; oral steroids above 10 mg - 3 week washout; psoralen + ultraviolet a light (puva) or ultraviolet b light (uvb) (including sunbathing, tanning beds, etc.) - 2 week washout; extracorporeal photopheresis - 2 week washout; electron beam - 2 weeks washout; chemotherapeutic agents - 3 week washout; bexarotene capsules or other oral biologics - 2 week washout; and topical nitrogen mustard - 2 week washout.
boolean
C2347852 (UMLS CUI [1])
pain
Item
uncontrolled pain.
boolean
C1557623 (UMLS CUI [1])
autoimmune disease; infection; hepatitis; active; hiv
Item
known history of autoimmune disease; or active hiv, htlv-1, and/or hepatitis infection.
boolean
C0004364 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
pregnant
Item
pregnant or lactating.
boolean
C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
local anesthesia; drugs
Item
have sensitivity to drugs that provide local anesthesia.
boolean
C0237865 (UMLS CUI [1])
carcinoma in situ; metastatic; prostate; exception; cervix; active; cancer; skin; non
Item
have active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.
boolean
C0006826 (UMLS CUI [1])
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