ID

38518

Beschrijving

Study of MOC31-PE in Antigen Positive Carcinomas; ODM derived from: https://clinicaltrials.gov/show/NCT01061645

Link

https://clinicaltrials.gov/show/NCT01061645

Trefwoorden

Versies (2)
  1. 23-10-19 23-10-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 oktober 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma NCT01061645

Engels

Eligibility Carcinoma NCT01061645

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01061645
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirm epithelial carcinoma, verified to be positive for the targeting antigen(ep-cam/epithelial glyco protein 2)according to the criteria given below.
Beschrijving

Carcinoma EPCAM gene Positive | Carcinoma EGP-2 antigen Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C0812305
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C0007097
UMLS CUI [2,2]
C1313303
UMLS CUI [2,3]
C1514241
tumor specimens verified to be positive for the targeting antibody,i.e.egp2 positive (moc31) by immunocytochemical or histochemical staining.
Beschrijving

Tumor tissue sample EGP-2 antigen Positive | Tumor tissue sample MOC31 Positive | Immunocytochemistry | Histochemistry

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1313303
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0812305
UMLS CUI [2,3]
C1514241
UMLS CUI [3]
C0242349
UMLS CUI [4]
C0019635
signed written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients with no clinically symptomatic central nervous system (cns) involvement.
Beschrijving

Central Nervous System Involvement Symptomatic Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0332197
both gender, age 18 -75 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of at least 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
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).
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0200633
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0201976
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0428321
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0201850
UMLS CUI [12]
C0202035
coagulation parameters (pt, ptt) within normal range.
Beschrijving

Blood coagulation Parameters | Prothrombin time assay | Activated Partial Thromboplastin Time measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005778
UMLS CUI [1,2]
C0449381
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0030605
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no medical history of hepatitis b or c infection
Beschrijving

Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
patients must have no ecg abnormalities
Beschrijving

ECG abnormality

Datatype

boolean

Alias
UMLS CUI [1]
C1832603
patients must not be hiv positive
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
female premenopausal patients should not be pregnant (must have a negative pregnancy test prior to inclusion) and should not be lactating.
Beschrijving

Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0427780
patients must use effective contraception if of reproductive potential.
Beschrijving

Females & males of reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
prior chemotherapy and/or radiation should be completed for at least 4 weeks prior to study enrolment
Beschrijving

Prior Chemotherapy Completed | Prior radiation therapy Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0205197
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Similar models

Eligibility Carcinoma NCT01061645

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01061645
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
Hepatitis B | Hepatitis C
Item
no medical history of hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1])
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])
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])
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])
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