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Information:
Fel:
ID
38518
Beskrivning
Study of MOC31-PE in Antigen Positive Carcinomas; ODM derived from: https://clinicaltrials.gov/show/NCT01061645
Länk
https://clinicaltrials.gov/show/NCT01061645
Nyckelord
Versioner (2)
- 2019-10-23 2019-10-23 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
23 oktober 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Carcinoma NCT01061645
Eligibility Carcinoma NCT01061645
- StudyEvent: Eligibility
Similar models
Eligibility Carcinoma NCT01061645
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Carcinoma EPCAM gene Positive | Carcinoma EGP-2 antigen Positive
Item
histologically confirm epithelial carcinoma, verified to be positive for the targeting antigen(ep-cam/epithelial glyco protein 2)according to the criteria given below.
boolean
C0007097 (UMLS CUI [1,1])
C0812305 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0007097 (UMLS CUI [2,1])
C1313303 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0812305 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0007097 (UMLS CUI [2,1])
C1313303 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Tumor tissue sample EGP-2 antigen Positive | Tumor tissue sample MOC31 Positive | Immunocytochemistry | Histochemistry
Item
tumor specimens verified to be positive for the targeting antibody,i.e.egp2 positive (moc31) by immunocytochemical or histochemical staining.
boolean
C0475358 (UMLS CUI [1,1])
C1313303 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C0812305 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0242349 (UMLS CUI [3])
C0019635 (UMLS CUI [4])
C1313303 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C0812305 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0242349 (UMLS CUI [3])
C0019635 (UMLS CUI [4])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Central Nervous System Involvement Symptomatic Absent
Item
patients with no clinically symptomatic central nervous system (cns) involvement.
boolean
C4050309 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age
Item
both gender, age 18 -75 years old.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Measurement of liver enzyme | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Gamma glutamyl transferase measurement
Item
adequate hematologic, renal and hepatic function defined as: neutrophils > 1.5 x 10^9/l;platelets > 100 x 10^9/l; creatinine < 120 umol/l; total bilirubin within normal range. liver enzymes (alat and asat <2.5 unl: alkaline phosphatase < 1.5 unl and ygt < 1.5 unl).
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0428321 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201850 (UMLS CUI [11])
C0202035 (UMLS CUI [12])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0428321 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201850 (UMLS CUI [11])
C0202035 (UMLS CUI [12])
Blood coagulation Parameters | Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
coagulation parameters (pt, ptt) within normal range.
boolean
C0005778 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
C0449381 (UMLS CUI [1,2])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
Hepatitis B | Hepatitis C
Item
no medical history of hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019196 (UMLS CUI [2])
ECG abnormality
Item
patients must have no ecg abnormalities
boolean
C1832603 (UMLS CUI [1])
HIV Seropositivity
Item
patients must not be hiv positive
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative
Item
female premenopausal patients should not be pregnant (must have a negative pregnancy test prior to inclusion) and should not be lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Females & males of reproductive potential Contraceptive methods
Item
patients must use effective contraception if of reproductive potential.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Prior Chemotherapy Completed | Prior radiation therapy Completed
Item
prior chemotherapy and/or radiation should be completed for at least 4 weeks prior to study enrolment
boolean
C1514457 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0205197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])