ID

28339

Beschrijving

Pre-therapeutic Identification of Dihydropyrimidine Dehydrogenase Gene (DPD) Deficiency for Predicting Toxicity to Fluoropyrimidines; ODM derived from: https://clinicaltrials.gov/show/NCT01547923

Link

https://clinicaltrials.gov/show/NCT01547923

Trefwoorden

Versies (1)
  1. 05-01-18 05-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01547923

Engels

Eligibility Colorectal Cancer NCT01547923

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
colorectal cancer, histologically confirmed, with all types included (including adjuvant cases), requiring treatment with intravenous 5-fluorouracil.
Beschrijving

Colorectal Carcinoma Type All | Adjuvant therapy | 5-Fluorouracil Intravenous Patient need for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0444868
UMLS CUI [2]
C0677850
UMLS CUI [3,1]
C0016360
UMLS CUI [3,2]
C1522726
UMLS CUI [3,3]
C0686904
anterior chemotherapy authorised, with the exception of chemotherapy containing a derivate of 5-fluorouracil
Beschrijving

Prior Chemotherapy | Exception 5-Fluorouracil Derivative

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0016360
UMLS CUI [2,3]
C1527240
age > or = 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
who performance status < or = 2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
haematologic and hepatic parameters : neutrophils > or = 1000 /mm3, platelets > or = 100000/mm3, total bilirubin < or = 2 x uln, ast and alt < or = 3 x uln, apl < or = 5 x uln
Beschrijving

Hematologic function | Liver function | Neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0032181
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0201850
complete initial assessment before first treatment administration for imaging and pharmacogenetic, within 15 days for biology, and within 7 days for clinical examination.
Beschrijving

Initial assessment Complete | Therapeutic procedure First Imaging | Therapeutic procedure First Pharmacogenetic Test | Therapeutic procedure First Test biological | Therapeutic procedure First Clinical examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0150637
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205435
UMLS CUI [2,3]
C0011923
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205435
UMLS CUI [3,3]
C2347500
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205435
UMLS CUI [4,3]
C0039593
UMLS CUI [4,4]
C0205460
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0205435
UMLS CUI [5,3]
C1456356
signed written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy with fluoropyrimidines
Beschrijving

fluoropyrimidine

Datatype

boolean

Alias
UMLS CUI [1]
C0596581
symptomatic or uncontrolled ventral nervous system metastases
Beschrijving

CNS metastases Symptomatic | CNS metastases Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205318
psychiatric disease disrupting the trial understanding and the enlightened and voluntary consent character
Beschrijving

Mental disorder Preventing Comprehension Study Protocol | Mental disorders Preventing Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
patient who is pregnant or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
woman not consenting to use adequate contraceptive precautions during the study
Beschrijving

Gender Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons
Beschrijving

Follow-up Unsuccessful Due to Psychological Factors | Follow-up Unsuccessful Due to Social factor | Follow-up Unsuccessful Due to Factor Familial | Follow-up Unsuccessful Due to Geographic Factors

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1272705
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0033898
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1272705
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0337460
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1272705
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C1521761
UMLS CUI [3,5]
C0241888
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C1272705
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0017444
significant serious pathology or any instable medical condition (cardiac pathology uncontrolled, myocardial infarction within 6 months before enrollment, systemic active uncontrolled infection)
Beschrijving

Pathology Serious | Medical condition Unstable | Heart Disease Uncontrolled | Myocardial Infarction | Sepsis Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0243026
UMLS CUI [5,2]
C0205318
any investigational agent within 4 weeks before enrollment
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Colorectal Cancer NCT01547923

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Type All | Adjuvant therapy | 5-Fluorouracil Intravenous Patient need for
Item
colorectal cancer, histologically confirmed, with all types included (including adjuvant cases), requiring treatment with intravenous 5-fluorouracil.
boolean
C0009402 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2])
C0016360 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
Prior Chemotherapy | Exception 5-Fluorouracil Derivative
Item
anterior chemotherapy authorised, with the exception of chemotherapy containing a derivate of 5-fluorouracil
boolean
C1514457 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
C1527240 (UMLS CUI [2,3])
Age
Item
age > or = 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who performance status < or = 2
boolean
C1298650 (UMLS CUI [1])
Hematologic function | Liver function | Neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
haematologic and hepatic parameters : neutrophils > or = 1000 /mm3, platelets > or = 100000/mm3, total bilirubin < or = 2 x uln, ast and alt < or = 3 x uln, apl < or = 5 x uln
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201850 (UMLS CUI [8])
Initial assessment Complete | Therapeutic procedure First Imaging | Therapeutic procedure First Pharmacogenetic Test | Therapeutic procedure First Test biological | Therapeutic procedure First Clinical examination
Item
complete initial assessment before first treatment administration for imaging and pharmacogenetic, within 15 days for biology, and within 7 days for clinical examination.
boolean
C0150637 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C2347500 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0205435 (UMLS CUI [4,2])
C0039593 (UMLS CUI [4,3])
C0205460 (UMLS CUI [4,4])
C0087111 (UMLS CUI [5,1])
C0205435 (UMLS CUI [5,2])
C1456356 (UMLS CUI [5,3])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
fluoropyrimidine
Item
prior chemotherapy with fluoropyrimidines
boolean
C0596581 (UMLS CUI [1])
CNS metastases Symptomatic | CNS metastases Uncontrolled
Item
symptomatic or uncontrolled ventral nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Mental disorder Preventing Comprehension Study Protocol | Mental disorders Preventing Informed Consent
Item
psychiatric disease disrupting the trial understanding and the enlightened and voluntary consent character
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
patient who is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Contraceptive methods Unwilling
Item
woman not consenting to use adequate contraceptive precautions during the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Follow-up Unsuccessful Due to Psychological Factors | Follow-up Unsuccessful Due to Social factor | Follow-up Unsuccessful Due to Factor Familial | Follow-up Unsuccessful Due to Geographic Factors
Item
patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons
boolean
C3274571 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0033898 (UMLS CUI [1,4])
C3274571 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0337460 (UMLS CUI [2,4])
C3274571 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C1521761 (UMLS CUI [3,4])
C0241888 (UMLS CUI [3,5])
C3274571 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0017444 (UMLS CUI [4,4])
Pathology Serious | Medical condition Unstable | Heart Disease Uncontrolled | Myocardial Infarction | Sepsis Uncontrolled
Item
significant serious pathology or any instable medical condition (cardiac pathology uncontrolled, myocardial infarction within 6 months before enrollment, systemic active uncontrolled infection)
boolean
C0677042 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0243026 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Investigational New Drugs
Item
any investigational agent within 4 weeks before enrollment
boolean
C0013230 (UMLS CUI [1])
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