Informationen:
Fehler:
ID
13000
Beschreibung
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
Stichworte
Versionen (1)
- 10.01.16 10.01.16 -
Hochgeladen am
10. Januar 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00041652
Eligibility Colorectal Cancer NCT00041652
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Colorectal Cancer NCT00041652
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])
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])
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])
C0032976 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C1321605 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0009488 (UMLS CUI [4,3])