ID

13000

Beschrijving

Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00041652

Link

https://clinicaltrials.gov/show/NCT00041652

Trefwoorden

  1. 10-01-16 10-01-16 -
Geüploaded op

10 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00041652

Eligibility Colorectal Cancer NCT00041652

Criteria
Beschrijving

Criteria

histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
Beschrijving

colonic, rectal or breast carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0699790
UMLS CUI [2]
C0007113
UMLS CUI [3]
C0678222
measurable lesion diagnosed by ct scan
Beschrijving

measurable disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C1513041
recurrent/metastatic disease considered surgically unresectable.
Beschrijving

unresectable: relapse, metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1519810
prior/concurrent therapy:
Beschrijving

concurrent therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0009429
chemotherapy: patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (enrollment must occur at least 4 weeks beyond last treatment)
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
other: prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study
Beschrijving

study subject participation status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
performance status: patients with a karnofsky performance status > 70% (or equivalent, ecog 0-1) and expected survival of at least 3 months.
Beschrijving

karnofsky, ecog, life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
UMLS CUI [3]
C0023671
hematopoietic: wbc >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, cea < 300 ng/ml
Beschrijving

wbc, neutrophils, platelets

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
hepatic: serum bilirubin </= 2.0 mg/dl, alt < 2.5 x iuln
Beschrijving

bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
cardiovascular: patients with lvef >/= 40% by required muga/2d-echo study.
Beschrijving

lvef

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
pulmonary: patients with fev1 >/= 60% by required pulmonary function tests
Beschrijving

fev1

Datatype

boolean

Alias
UMLS CUI [1]
C0748133
other: patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. a pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent. patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.
Beschrijving

contraception, pregnancy test, informed consent, comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032976
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0009488

Similar models

Eligibility Colorectal Cancer NCT00041652

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
colonic, rectal or breast carcinoma
Item
histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
boolean
C0699790 (UMLS CUI [1])
C0007113 (UMLS CUI [2])
C0678222 (UMLS CUI [3])
measurable disease
Item
measurable lesion diagnosed by ct scan
boolean
C0040405 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
unresectable: relapse, metastasis
Item
recurrent/metastatic disease considered surgically unresectable.
boolean
C0277556 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
concurrent therapy
Item
prior/concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
chemotherapy
Item
chemotherapy: patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (enrollment must occur at least 4 weeks beyond last treatment)
boolean
C0392920 (UMLS CUI [1])
study subject participation status
Item
other: prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study
boolean
C2348568 (UMLS CUI [1])
karnofsky, ecog, life expectancy
Item
performance status: patients with a karnofsky performance status > 70% (or equivalent, ecog 0-1) and expected survival of at least 3 months.
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
wbc, neutrophils, platelets
Item
hematopoietic: wbc >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, cea < 300 ng/ml
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
bilirubin
Item
hepatic: serum bilirubin </= 2.0 mg/dl, alt < 2.5 x iuln
boolean
C1278039 (UMLS CUI [1])
lvef
Item
cardiovascular: patients with lvef >/= 40% by required muga/2d-echo study.
boolean
C0428772 (UMLS CUI [1])
fev1
Item
pulmonary: patients with fev1 >/= 60% by required pulmonary function tests
boolean
C0748133 (UMLS CUI [1])
contraception, pregnancy test, informed consent, comorbidity
Item
other: patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. a pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent. patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.
boolean
C0700589 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C1321605 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0009488 (UMLS CUI [4,3])

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