ID

31046

Beschrijving

A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00680940

Link

https://clinicaltrials.gov/show/NCT00680940

Trefwoorden

Versies (1)
  1. 13-07-18 13-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00680940

Engels

Eligibility Non Small Cell Lung Cancer NCT00680940

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to understand and the willingness to sign a written informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
histologically or cytologically confirmed non-small cell cancer, stage iiib or iv.
Beschrijving

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
age should be 18 years or above.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog should be in 0-1 range.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count ≥ 1,00,000/mm3
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin ≥ 9.0g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
ast and alt ≤ 2.5 times upper limit of normal (uln)range of institution (5times uln if liver metastasis present).
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
bilirubin not greater than 1.5 times uln range of institution (3 times uln if liver involvement).
Beschrijving

Serum total bilirubin measurement | Relationship Involvement with Liver

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0023884
creatinine ≤ upper limit of normal (uln) range of institution.
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
negative pregnancy test for women of child bearing potential prior to entry into the trial.
Beschrijving

Childbearing Potential Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
Beschrijving

Cytotoxic Chemotherapy | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C1522449
patient with systematic brain metastasis.
Beschrijving

Metastatic malignant neoplasm to brain systematic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0220922
history of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
Beschrijving

Paclitaxel allergy | Cisplatin allergy | Allergic Reaction Mycobacterium w | Allergic Reaction Paclitaxel Ingredient | Allergic Reaction Cisplatin Ingredient | Allergic Reaction Mycobacterium w Ingredient

Datatype

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2]
C0570702
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1940778
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0144576
UMLS CUI [4,3]
C1550600
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0008838
UMLS CUI [5,3]
C1550600
UMLS CUI [6,1]
C1527304
UMLS CUI [6,2]
C1940778
UMLS CUI [6,3]
C1550600
pregnant women or nursing women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
uncontrolled intercurrent illness that would limit compliance with study requirements.
Beschrijving

Comorbidity Uncontrolled | Protocol Compliance Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0439801
hiv positive patients.
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
previous splenectomy.
Beschrijving

Splenectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0037995
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00680940

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically or cytologically confirmed non-small cell cancer, stage iiib or iv.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
age should be 18 years or above.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog should be in 0-1 range.
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1,00,000/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9.0g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
ast and alt ≤ 2.5 times upper limit of normal (uln)range of institution (5times uln if liver metastasis present).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Serum total bilirubin measurement | Relationship Involvement with Liver
Item
bilirubin not greater than 1.5 times uln range of institution (3 times uln if liver involvement).
boolean
C1278039 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
Creatinine measurement, serum
Item
creatinine ≤ upper limit of normal (uln) range of institution.
boolean
C0201976 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women of child bearing potential prior to entry into the trial.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy | Therapeutic radiology procedure
Item
patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
boolean
C0677881 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Metastatic malignant neoplasm to brain systematic
Item
patient with systematic brain metastasis.
boolean
C0220650 (UMLS CUI [1,1])
C0220922 (UMLS CUI [1,2])
Paclitaxel allergy | Cisplatin allergy | Allergic Reaction Mycobacterium w | Allergic Reaction Paclitaxel Ingredient | Allergic Reaction Cisplatin Ingredient | Allergic Reaction Mycobacterium w Ingredient
Item
history of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
boolean
C0570707 (UMLS CUI [1])
C0570702 (UMLS CUI [2])
C1527304 (UMLS CUI [3,1])
C1940778 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0144576 (UMLS CUI [4,2])
C1550600 (UMLS CUI [4,3])
C1527304 (UMLS CUI [5,1])
C0008838 (UMLS CUI [5,2])
C1550600 (UMLS CUI [5,3])
C1527304 (UMLS CUI [6,1])
C1940778 (UMLS CUI [6,2])
C1550600 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
pregnant women or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled | Protocol Compliance Limited
Item
uncontrolled intercurrent illness that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
HIV Seropositivity
Item
hiv positive patients.
boolean
C0019699 (UMLS CUI [1])
Splenectomy
Item
previous splenectomy.
boolean
C0037995 (UMLS CUI [1])
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