ID

13101

Beschrijving

A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02228785

Link

https://clinicaltrials.gov/show/NCT02228785

Trefwoorden

Versies (1)
  1. 17-01-16 17-01-16 -
Geüploaded op

17 januari 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02228785

Engels

Eligibility Colorectal Cancer NCT02228785

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0009402
UMLS CUI [2,2]
C0001418
recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
Beschrijving

recurrent disease, surgery, radiotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C0038894
UMLS CUI [3]
C1522449
life expectancy greater than 3 months.
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
karnofsky index score greater than or equal to 50%.
Beschrijving

karnofsky

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
written informed consent obtained.
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through stage i.
Beschrijving

malignancies

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0302592
acute intercurrent illness.
Beschrijving

acute intercurrent illness.

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
Beschrijving

patient medical risk due to systemic disease or grossly abnormal laboratory results

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients who had received any other anticancer therapy within 3 months.
Beschrijving

cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with h2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
Beschrijving

condition affectin serum gastrin or gastric acidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0202036
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0017120
patients immunologically compromised including those on corticosteroid therapy.
Beschrijving

immunocompromised, steroid therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2]
C0149783
women of child-bearing age.
Beschrijving

child-bearing age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
UMLS CUI [3]
C1960468
positive immediate hypersensitivity reaction to skin testing with study medication.
Beschrijving

hypernsensitivity protocol agent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1521826
patients unable to complete the diary book
Beschrijving

unable to complete the diary book

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
haematogical status haemoglobin count less than 10g/dl white blood cell count less than 4.0 x 10^9/l platelet count less than 100 x 10^9/l
Beschrijving

hemoglobin, white blood cell count, platelet count

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0005821
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Similar models

Eligibility Colorectal Cancer NCT02228785

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
boolean
C0001779 (UMLS CUI [1])
C0009402 (UMLS CUI [2,1])
C0001418 (UMLS CUI [2,2])
recurrent disease, surgery, radiotherapy
Item
recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
boolean
C0277556 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0038894 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
life expectancy
Item
life expectancy greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
karnofsky
Item
karnofsky index score greater than or equal to 50%.
boolean
C0206065 (UMLS CUI [1])
written informed consent
Item
written informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
malignancies
Item
neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through stage i.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0302592 (UMLS CUI [3])
acute intercurrent illness.
Item
acute intercurrent illness.
boolean
C0009488 (UMLS CUI [1])
patient medical risk due to systemic disease or grossly abnormal laboratory results
Item
patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
cancer treatment
Item
patients who had received any other anticancer therapy within 3 months.
boolean
C0920425 (UMLS CUI [1])
condition affectin serum gastrin or gastric acidity
Item
factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with h2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0202036 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0017120 (UMLS CUI [2,3])
immunocompromised, steroid therapy
Item
patients immunologically compromised including those on corticosteroid therapy.
boolean
C0085393 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
child-bearing age
Item
women of child-bearing age.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C1960468 (UMLS CUI [3])
hypernsensitivity protocol agent
Item
positive immediate hypersensitivity reaction to skin testing with study medication.
boolean
C0020517 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
unable to complete the diary book
Item
patients unable to complete the diary book
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
hemoglobin, white blood cell count, platelet count
Item
haematogical status haemoglobin count less than 10g/dl white blood cell count less than 4.0 x 10^9/l platelet count less than 100 x 10^9/l
boolean
C0019046 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
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