ID

23731

Beschrijving

Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin; ODM derived from: https://clinicaltrials.gov/show/NCT00884767

Link

https://clinicaltrials.gov/show/NCT00884767

Trefwoorden

Versies (1)
  1. 12-07-17 12-07-17 -
Geüploaded op

12 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chemotherapeutic Agent Toxicity NCT00884767

Engels

Eligibility Chemotherapeutic Agent Toxicity NCT00884767

1 Formulieren  
Criteria
Beschrijving

Criteria

histologically confirmed colorectal cancer
Beschrijving

Colorectal Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0009402
requires treatment with oxaliplatin (as part of a folfox regimen)
Beschrijving

Oxaliplatin Patient need for | FOLFOX Regimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0069717
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0392943
no brain metastases or symptomatic meningitis
Beschrijving

Metastatic malignant neoplasm to brain Absent | Meningitis Symptomatic Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0025289
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0332197
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
who performance status 0-2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy > 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
anc ≥ 1 x 10^9/l
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100 x 10^9/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin ≤ 2 times upper limit of normal (uln)
Beschrijving

Elevated total bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0741494
transaminases ≤ 3 times uln
Beschrijving

Serum transaminase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0859350
alkaline phosphatase ≤ 5 times uln
Beschrijving

Alkaline phosphatase raised

Datatype

boolean

Alias
UMLS CUI [1]
C0151849
not pregnant or nursing
Beschrijving

Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
fertile patients must use effective contraception
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no prior or concurrent clinical neuropathy (regardless of the etiology)
Beschrijving

Neuropathy Clinical Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0332197
no dihydropyrimidine dehydrogenase deficiency
Beschrijving

Dihydropyrimidine Dehydrogenase Deficiency Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1959620
UMLS CUI [1,2]
C0332197
no psychiatric illness that would preclude comprehension of the study or of the informed consent
Beschrijving

Exclusion Criteria | Mental disorders Preventing Comprehension Study Protocol | Mental disorders Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C1299582
no other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection
Beschrijving

Exclusion Criteria | Illness Severe Worsening | Heart Diseases Unstable | Myocardial Infarction | Communicable Diseases Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332271
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205318
no psychological, social, familial, or geographical reason that would preclude study follow-up
Beschrijving

Exclusion Criteria | Psychological Factors Preventing Clinical Study Follow-up | Social situation Preventing Clinical Study Follow-up | Problem Familial Preventing Clinical Study Follow-up | Geographical environment Preventing Clinical Study Follow-up

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0033898
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C0748872
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C3274571
UMLS CUI [4,1]
C0033213
UMLS CUI [4,2]
C0241888
UMLS CUI [4,3]
C1292733
UMLS CUI [4,4]
C3274571
UMLS CUI [5,1]
C0565935
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C3274571
other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes
Beschrijving

Malignant Neoplasms | Therapeutic procedure Without Platinum derivatives | Therapeutic procedure Without Taxanes

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0032207
UMLS CUI [2,4]
C0243072
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332288
UMLS CUI [3,3]
C0796419
prior concurrent therapy:
Beschrijving

Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Beschrijving

ID.21

Datatype

boolean

prior chemotherapy allowed (except for platinum derivatives or taxanes)
Beschrijving

Prior Chemotherapy | Platinum derivatives | Taxanes

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0032207
UMLS CUI [2,2]
C0243072
UMLS CUI [3]
C0796419
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Similar models

Eligibility Chemotherapeutic Agent Toxicity NCT00884767

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Colorectal Carcinoma
Item
histologically confirmed colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Oxaliplatin Patient need for | FOLFOX Regimen
Item
requires treatment with oxaliplatin (as part of a folfox regimen)
boolean
C0069717 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0392943 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Absent | Meningitis Symptomatic Absent
Item
no brain metastases or symptomatic meningitis
boolean
C0220650 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0025289 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count
Item
anc ≥ 1 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin ≤ 2 times upper limit of normal (uln)
boolean
C0741494 (UMLS CUI [1])
Serum transaminase increased
Item
transaminases ≤ 3 times uln
boolean
C0859350 (UMLS CUI [1])
Alkaline phosphatase raised
Item
alkaline phosphatase ≤ 5 times uln
boolean
C0151849 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Neuropathy Clinical Absent
Item
no prior or concurrent clinical neuropathy (regardless of the etiology)
boolean
C0442874 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Dihydropyrimidine Dehydrogenase Deficiency Absent
Item
no dihydropyrimidine dehydrogenase deficiency
boolean
C1959620 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Exclusion Criteria | Mental disorders Preventing Comprehension Study Protocol | Mental disorders Informed Consent Unable
Item
no psychiatric illness that would preclude comprehension of the study or of the informed consent
boolean
C0680251 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Exclusion Criteria | Illness Severe Worsening | Heart Diseases Unstable | Myocardial Infarction | Communicable Diseases Uncontrolled
Item
no other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection
boolean
C0680251 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332271 (UMLS CUI [2,3])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Exclusion Criteria | Psychological Factors Preventing Clinical Study Follow-up | Social situation Preventing Clinical Study Follow-up | Problem Familial Preventing Clinical Study Follow-up | Geographical environment Preventing Clinical Study Follow-up
Item
no psychological, social, familial, or geographical reason that would preclude study follow-up
boolean
C0680251 (UMLS CUI [1])
C0033898 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C0748872 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C0033213 (UMLS CUI [4,1])
C0241888 (UMLS CUI [4,2])
C1292733 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
C0565935 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
Malignant Neoplasms | Therapeutic procedure Without Platinum derivatives | Therapeutic procedure Without Taxanes
Item
other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes
boolean
C0006826 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0032207 (UMLS CUI [2,3])
C0243072 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0796419 (UMLS CUI [3,3])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
ID.21
Item
see disease characteristics
boolean
Prior Chemotherapy | Platinum derivatives | Taxanes
Item
prior chemotherapy allowed (except for platinum derivatives or taxanes)
boolean
C1514457 (UMLS CUI [1])
C0032207 (UMLS CUI [2,1])
C0243072 (UMLS CUI [2,2])
C0796419 (UMLS CUI [3])
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