ID

13101

Description

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

Lien

https://clinicaltrials.gov/show/NCT02228785

Mots-clés

Versions (1)
  1. 17/01/2016 17/01/2016 -
Téléchargé le

17 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02228785

Anglais

Eligibility Colorectal Cancer NCT02228785

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

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.
Description

recurrent disease, surgery, radiotherapy

Type de données

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.
Description

life expectancy

Type de données

boolean

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

karnofsky

Type de données

boolean

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

written informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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.
Description

malignancies

Type de données

boolean

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

acute intercurrent illness.

Type de données

boolean

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

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

Type de données

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.
Description

cancer treatment

Type de données

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.
Description

condition affectin serum gastrin or gastric acidity

Type de données

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.
Description

immunocompromised, steroid therapy

Type de données

boolean

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

child-bearing age

Type de données

boolean

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

hypernsensitivity protocol agent

Type de données

boolean

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

unable to complete the diary book

Type de données

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
Description

hemoglobin, white blood cell count, platelet count

Type de données

boolean

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

Eligibility Colorectal Cancer NCT02228785

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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