ID

23731

Description

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

Keywords

Versions (1)
  1. 7/12/17 7/12/17 -
Uploaded on

July 12, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Chemotherapeutic Agent Toxicity NCT00884767

English

Eligibility Chemotherapeutic Agent Toxicity NCT00884767

1 forms  
Criteria
Description

Criteria

histologically confirmed colorectal cancer
Description

Colorectal Carcinoma

Data type

boolean

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

Oxaliplatin Patient need for | FOLFOX Regimen

Data type

boolean

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

Metastatic malignant neoplasm to brain Absent | Meningitis Symptomatic Absent

Data type

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:
Description

Client Characteristics

Data type

boolean

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

WHO performance status scale

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Absolute neutrophil count

Data type

boolean

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

Platelet Count measurement

Data type

boolean

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

Elevated total bilirubin

Data type

boolean

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

Serum transaminase increased

Data type

boolean

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

Alkaline phosphatase raised

Data type

boolean

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

Pregnancy Absent | Breast Feeding Absent

Data type

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
Description

Fertility Contraceptive methods

Data type

boolean

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

Neuropathy Clinical Absent

Data type

boolean

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

Dihydropyrimidine Dehydrogenase Deficiency Absent

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Description

ID.21

Data type

boolean

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

Prior Chemotherapy | Platinum derivatives | Taxanes

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0032207
UMLS CUI [2,2]
C0243072
UMLS CUI [3]
C0796419
Back to the top of the page

Similar models

Eligibility Chemotherapeutic Agent Toxicity NCT00884767

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial