ID

13000

Description

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

Keywords

Versions (1)
  1. 1/10/16 1/10/16 -
Uploaded on

January 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00041652

English

Eligibility Colorectal Cancer NCT00041652

1 forms  
Criteria
Description

Criteria

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

colonic, rectal or breast carcinoma

Data type

boolean

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

measurable disease

Data type

boolean

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

unresectable: relapse, metastasis

Data type

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:
Description

concurrent therapy

Data type

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)
Description

chemotherapy

Data type

boolean

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

study subject participation status

Data type

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.
Description

karnofsky, ecog, life expectancy

Data type

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
Description

wbc, neutrophils, platelets

Data type

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
Description

bilirubin

Data type

boolean

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

lvef

Data type

boolean

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

fev1

Data type

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.
Description

contraception, pregnancy test, informed consent, comorbidity

Data type

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
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Similar models

Eligibility Colorectal Cancer NCT00041652

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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