ID

39865

Description

ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA; ODM derived from: https://clinicaltrials.gov/show/NCT01730612

Link

https://clinicaltrials.gov/show/NCT01730612

Keywords

Versions (1)
  1. 2/25/20 2/25/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 25, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility HER2 Negative Breast Carcinoma Expressing CEA NCT01730612

English

Eligibility HER2 Negative Breast Carcinoma Expressing CEA NCT01730612

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast carcinoma, her2 + (dako) and her2 + (fish) metastatic at least after treatment with current consensus
Description

HER2-positive carcinoma of breast metastatic FISH | Status post Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C0162789
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0087111
≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
negative pregnancy test for women of childbearing age. women of childbearing age should take effective contraception continuously for 3 months.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
karnofsky ≥ 70 or ecog 0-1
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of at least 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ace of the tumor by immunohistochemistry or positive plasma cea ≥ 10 ng / ml
Description

ACE Tumor Immunohistochemistry | Plasma CEA measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0022709
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0201933
at least one measurable lesion on ct
Description

Measurable lesion Quantity CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0040405
creatinine < 2.5
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
informed consent signed
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
social insurance
Description

Social insurance

Data type

boolean

Alias
UMLS CUI [1]
C0037435
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious illness or co-morbidity risk assessed
Description

Illness Serious | Comorbidity Risk Assessed

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C1516048
history of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix
Description

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
presence of anti-antibodies in patients who have previously received antibodies
Description

Anti-Antibodies | Patients Antibodies Previous

Data type

boolean

Alias
UMLS CUI [1]
C1624602
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0205156
known hypersensitivity to antibodies or proteins
Description

Hypersensitivity Antibodies | Protein allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003241
UMLS CUI [2]
C1112677
intellectual disability to sign the informed consent
Description

Intellectual Disability | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1]
C3714756
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
persons protected by law
Description

Protection of patient Legal

Data type

boolean

Alias
UMLS CUI [1,1]
C0412786
UMLS CUI [1,2]
C1301860
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Similar models

Eligibility HER2 Negative Breast Carcinoma Expressing CEA NCT01730612

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
HER2-positive carcinoma of breast metastatic FISH | Status post Treatment
Item
breast carcinoma, her2 + (dako) and her2 + (fish) metastatic at least after treatment with current consensus
boolean
C1960398 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Age
Item
≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
negative pregnancy test for women of childbearing age. women of childbearing age should take effective contraception continuously for 3 months.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Karnofsky Performance Status
Item
karnofsky ≥ 70 or ecog 0-1
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
ACE Tumor Immunohistochemistry | Plasma CEA measurement
Item
ace of the tumor by immunohistochemistry or positive plasma cea ≥ 10 ng / ml
boolean
C0022709 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0032105 (UMLS CUI [2,1])
C0201933 (UMLS CUI [2,2])
Measurable lesion Quantity CT
Item
at least one measurable lesion on ct
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
creatinine < 2.5
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
informed consent signed
boolean
C0021430 (UMLS CUI [1])
Social insurance
Item
social insurance
boolean
C0037435 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious | Comorbidity Risk Assessed
Item
serious illness or co-morbidity risk assessed
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Anti-Antibodies | Patients Antibodies Previous
Item
presence of anti-antibodies in patients who have previously received antibodies
boolean
C1624602 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Hypersensitivity Antibodies | Protein allergy
Item
known hypersensitivity to antibodies or proteins
boolean
C0020517 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
C1112677 (UMLS CUI [2])
Intellectual Disability | Informed Consent Unable
Item
intellectual disability to sign the informed consent
boolean
C3714756 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Diabetes Mellitus
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Protection of patient Legal
Item
persons protected by law
boolean
C0412786 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
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