ID

38518

Description

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

Link

https://clinicaltrials.gov/show/NCT01061645

Keywords

Versions (2)
  1. 10/23/19 10/23/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 23, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Carcinoma NCT01061645

English

Eligibility Carcinoma NCT01061645

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01061645
Inclusion Criteria
Description

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.
Description

Carcinoma EPCAM gene Positive | Carcinoma EGP-2 antigen Positive

Data type

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.
Description

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

Data type

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
Description

Informed Consent

Data type

boolean

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

Central Nervous System Involvement Symptomatic Absent

Data type

boolean

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

Age

Data type

boolean

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

Life Expectancy

Data type

boolean

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

ECOG performance status

Data type

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).
Description

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

Data type

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.
Description

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

Data type

boolean

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

Exclusion Criteria

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

Hepatitis B | Hepatitis C

Data type

boolean

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

ECG abnormality

Data type

boolean

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

HIV Seropositivity

Data type

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.
Description

Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative

Data type

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.
Description

Females & males of reproductive potential Contraceptive methods

Data type

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
Description

Prior Chemotherapy Completed | Prior radiation therapy Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0205197
Back to the top of the page

Similar models

Eligibility Carcinoma NCT01061645

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01061645
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial