ID

37768

Beschrijving

VEGF Early Imaging for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00991978

Link

https://clinicaltrials.gov/show/NCT00991978

Trefwoorden

Versies (1)
  1. 22-08-19 22-08-19 -
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See clinicaltrials.gov

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22 augustus 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00991978

Engels

Eligibility Breast Cancer NCT00991978

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a breast tumor size < 2 cm in diameter (as determined by means of conventional imaging techniques: mammography, ultrasound or mri) who are scheduled to receive operative intervention either by means of a mastectomy or lumpectomy.
Beschrijving

Breast Carcinoma Diameter Imaging Techniques | Breast Carcinoma Diameter Mammography | Breast Carcinoma Diameter Ultrasonography | Breast Carcinoma Diameter MRI | Operative Surgical Procedure Scheduled | Mastectomy | Lumpectomy of breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0079595
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0024671
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0041618
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0205539
UMLS CUI [6]
C0024881
UMLS CUI [7]
C0851238
histologically proven breast cancer
Beschrijving

Breast Carcinoma Histology

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0344441
age > 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
who performance status 0-2 (see: appendix b)
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
signed written informed consent (approved by the institutional review board [irb]/
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
independent ethics committee [iec]) obtained prior to any study specific screening procedures.
Beschrijving

ID.6

Datatype

boolean

able to comply with the protocol.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
other invasive malignancy or condition which could affect compliance with the protocol or interpretation of results.
Beschrijving

Invasive cancer Affecting Protocol Compliance | Condition Affecting Protocol Compliance | Invasive cancer Affecting Interpretation Research results | Condition Affecting Interpretation Research results

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0677898
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0683954
pregnant or lactating women. documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
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
prior radiotherapy on the involved area.
Beschrijving

Prior radiation therapy Area Involved

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1314939
major surgery within 28 days before the initiation of the study.
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
clinically significant cardiovascular disease.
Beschrijving

Cardiovascular Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Beschrijving

Allergic Reaction Immunoglobulins | Hypersensitivity Immunoglobulins

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0021027
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021027
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Similar models

Eligibility Breast Cancer NCT00991978

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Diameter Imaging Techniques | Breast Carcinoma Diameter Mammography | Breast Carcinoma Diameter Ultrasonography | Breast Carcinoma Diameter MRI | Operative Surgical Procedure Scheduled | Mastectomy | Lumpectomy of breast
Item
patients with a breast tumor size < 2 cm in diameter (as determined by means of conventional imaging techniques: mammography, ultrasound or mri) who are scheduled to receive operative intervention either by means of a mastectomy or lumpectomy.
boolean
C0678222 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0079595 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0024671 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
C0678222 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C0024881 (UMLS CUI [6])
C0851238 (UMLS CUI [7])
Breast Carcinoma Histology
Item
histologically proven breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2 (see: appendix b)
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent (approved by the institutional review board [irb]/
boolean
C0021430 (UMLS CUI [1])
ID.6
Item
independent ethics committee [iec]) obtained prior to any study specific screening procedures.
boolean
Protocol Compliance
Item
able to comply with the protocol.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Invasive cancer Affecting Protocol Compliance | Condition Affecting Protocol Compliance | Invasive cancer Affecting Interpretation Research results | Condition Affecting Interpretation Research results
Item
other invasive malignancy or condition which could affect compliance with the protocol or interpretation of results.
boolean
C0677898 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0677898 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative
Item
pregnant or lactating women. documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Prior radiation therapy Area Involved
Item
prior radiotherapy on the involved area.
boolean
C0279134 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Major surgery
Item
major surgery within 28 days before the initiation of the study.
boolean
C0679637 (UMLS CUI [1])
Cardiovascular Disease
Item
clinically significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
Allergic Reaction Immunoglobulins | Hypersensitivity Immunoglobulins
Item
prior allergic reaction to immunoglobulins or immunoglobulin allergy.
boolean
C1527304 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0021027 (UMLS CUI [2,2])
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