ID

13001

Description

Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT02223078

Link

https://clinicaltrials.gov/show/NCT02223078

Keywords

Versions (1)
  1. 1/10/16 1/10/16 -
Uploaded on

January 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02223078

English

Eligibility Colorectal Cancer NCT02223078

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
Description

histology colorectal carcinoma, therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0009402
UMLS CUI [2]
C0087111
patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
Description

proton pump inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0358591
proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
Description

proton pump inhibitor compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0358591
UMLS CUI [1,2]
C1321605
male or female patients from 18 to 65 years of age.
Description

gender, age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patients with a life expectancy of over three months.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
world health organisation (who) performance status of 0 to 1.
Description

who performance status

Data type

boolean

Alias
UMLS CUI [1]
C1298650
written informed consent given.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients in receipt of histamine h2-receptor (h2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
Description

histamine h2 antagonists, antiacids

Data type

boolean

Alias
UMLS CUI [1]
C0019593
UMLS CUI [2]
C0003138
patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
Description

gastric acidity

Data type

boolean

Alias
UMLS CUI [1]
C0017120
history of other malignant disease within the previous five years, except non-
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
melanomatous skin cancer or in situ carcinoma of the uterine cervix.
Description

melanoma, cervix carcinoma in situ

Data type

boolean

Alias
UMLS CUI [1]
C0025202
UMLS CUI [2]
C0851140
previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
Description

radiotherapy, chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
Description

immunosuppressants

Data type

boolean

Alias
UMLS CUI [1]
C0021081
females who were pregnant, planning to become pregnant or lactating. women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
Description

pregnancy, lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study.
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
previous g 17dt treatment.
Description

G17DT

Data type

boolean

Alias
UMLS CUI [1]
C0935889
haematological indicators: haemoglobin <10.0 g/dl white blood cell count <4.0 x 109/l platelets < 100 x 1 09/l
Description

haemoglobin, wbc, platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
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Similar models

Eligibility Colorectal Cancer NCT02223078

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
histology colorectal carcinoma, therapy
Item
patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
boolean
C0019638 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
proton pump inhibitor
Item
patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
boolean
C0358591 (UMLS CUI [1])
proton pump inhibitor compliance
Item
proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
boolean
C0358591 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
gender, age
Item
male or female patients from 18 to 65 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
life expectancy
Item
patients with a life expectancy of over three months.
boolean
C0023671 (UMLS CUI [1])
who performance status
Item
world health organisation (who) performance status of 0 to 1.
boolean
C1298650 (UMLS CUI [1])
informed consent
Item
written informed consent given.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
histamine h2 antagonists, antiacids
Item
patients in receipt of histamine h2-receptor (h2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
boolean
C0019593 (UMLS CUI [1])
C0003138 (UMLS CUI [2])
gastric acidity
Item
patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
boolean
C0017120 (UMLS CUI [1])
malignancy
Item
history of other malignant disease within the previous five years, except non-
boolean
C0006826 (UMLS CUI [1])
melanoma, cervix carcinoma in situ
Item
melanomatous skin cancer or in situ carcinoma of the uterine cervix.
boolean
C0025202 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
radiotherapy, chemotherapy
Item
previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
immunosuppressants
Item
concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
boolean
C0021081 (UMLS CUI [1])
pregnancy, lactation
Item
females who were pregnant, planning to become pregnant or lactating. women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
study subject participation status
Item
patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study.
boolean
C2348568 (UMLS CUI [1])
G17DT
Item
previous g 17dt treatment.
boolean
C0935889 (UMLS CUI [1])
haemoglobin, wbc, platelet count
Item
haematological indicators: haemoglobin <10.0 g/dl white blood cell count <4.0 x 109/l platelets < 100 x 1 09/l
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
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