ID

31688

Description

A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02035657

Link

https://clinicaltrials.gov/show/NCT02035657

Keywords

Versions (2)
  1. 9/21/18 9/21/18 -
  2. 9/21/18 9/21/18 -
Copyright Holder

Immune Design

Uploaded on

September 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Merkel Cell Carcinoma NCT02035657

English

Eligibility Merkel Cell Carcinoma NCT02035657

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy-confirmed merkel cell carcinoma with metastatic or loco-regional disease.
Description

biopsy-confirmed merkel cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0007129
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0007129
UMLS CUI [2,2]
C1947913
patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable it injection.
Description

Lesion must be palpable (superficial) and injectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0746412
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1272883
UMLS CUI [2,3]
C0332149
ecog performance status score 0, 1 or 2
Description

ECOG Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of ≥ three months.
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate neutrophil and platelet counts
Description

neutrophil and platelet counts

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
adequate renal and hepatic function
Description

Renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
Description

willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C2709094
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C2709088
use of effective contraception
Description

Contraception status

Data type

boolean

Alias
UMLS CUI [1]
C0420837
signed informed consent document
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
members of all genders, races and ethnic groups are eligible for this trial
Description

Gender and ethnicity

Data type

boolean

Alias
UMLS CUI [1]
C0015031
UMLS CUI [2]
C0079399
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
Description

Prior chemotherapy or surgery or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332185
no concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
Description

No concurrent anti-cancer treatment or investigational drugs

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
active, untreated brain metastases
Description

Untreated brain metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
pregnant or nursing
Description

Pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
use of any systemic immunosuppressive agents
Description

use of systemic immunosuppressive agents

Data type

boolean

Alias
UMLS CUI [1]
C0021079
immunosuppressed patients
Description

Immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C4048329
uncontrolled depression or other major psychiatric disorder
Description

Psychiatric comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0004936
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Similar models

Eligibility Merkel Cell Carcinoma NCT02035657

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
biopsy-confirmed merkel cell carcinoma
Item
biopsy-confirmed merkel cell carcinoma with metastatic or loco-regional disease.
boolean
C0007129 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0007129 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
Lesion must be palpable (superficial) and injectable
Item
patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable it injection.
boolean
C0221198 (UMLS CUI [1,1])
C0746412 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1272883 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
ECOG Status
Item
ecog performance status score 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
life expectancy of ≥ three months.
boolean
C0023671 (UMLS CUI [1])
neutrophil and platelet counts
Item
adequate neutrophil and platelet counts
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
Renal and hepatic function
Item
adequate renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
Item
willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
boolean
C0600109 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
C0600109 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C2709088 (UMLS CUI [2,3])
Contraception status
Item
use of effective contraception
boolean
C0420837 (UMLS CUI [1])
Informed consent
Item
signed informed consent document
boolean
C0021430 (UMLS CUI [1])
Gender and ethnicity
Item
members of all genders, races and ethnic groups are eligible for this trial
boolean
C0015031 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior chemotherapy or surgery or radiotherapy
Item
prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
boolean
C1514457 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
No concurrent anti-cancer treatment or investigational drugs
Item
no concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Untreated brain metastases
Item
active, untreated brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Pregnant or nursing
Item
pregnant or nursing
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
use of systemic immunosuppressive agents
Item
use of any systemic immunosuppressive agents
boolean
C0021079 (UMLS CUI [1])
Immunosuppression
Item
immunosuppressed patients
boolean
C4048329 (UMLS CUI [1])
Psychiatric comorbidity
Item
uncontrolled depression or other major psychiatric disorder
boolean
C0004936 (UMLS CUI [1])
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