ID

38256

Description

Gadofosveset for Axillary Staging in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01437865

Link

https://clinicaltrials.gov/show/NCT01437865

Keywords

Versions (1)
  1. 10/4/19 10/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01437865

English

Eligibility Breast Neoplasms NCT01437865

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
Description

Invasive carcinoma of breast | Lymph nodes TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C3258246
2. tumor must be a t2 according the tnm 6-classification.
Description

Neoplasm TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0474926
3. the ultrasound of the axilla must be suspect for nodal metastases.
Description

Axilla Ultrasound | Secondary malignant neoplasm of lymph node Suspected

Data type

boolean

Alias
UMLS CUI [1]
C4484660
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0750491
4. willing and able to undergo all study procedures
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
5. has personally provided written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age <18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. history of prior chemotherapy
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
3. history of prior radiotherapy of the surrounding areas of the axilla.
Description

Prior radiation therapy Axilla Area

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0004454
UMLS CUI [1,3]
C0205146
4. pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
5. contra indications for mri such as pacemaker, aneurysm clips or severe claustrophobia.
Description

Medical contraindication MRI | Artificial cardiac pacemaker | Aneurysm clip | Claustrophobia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0179977
UMLS CUI [4,1]
C0008909
UMLS CUI [4,2]
C0205082
6. allergy to any of the ingredients of gadofosveset (vasovist® /ablavar®)
Description

Hypersensitivity Gadofosveset Ingredient | Hypersensitivity Vasovist | Hypersensitivity Ablavar

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1698893
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1743039
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2746922
7. being unable to give informed consent in person
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
8. acute or chronic severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2).
Description

Renal Insufficiency Severe | Renal Insufficiency Severe chronic | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205191
UMLS CUI [3]
C0017654
9. acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
Description

Renal Insufficiency Severity Any | Etiology Hepatorenal Syndrome | Transplantation of liver perioperative

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0019212
UMLS CUI [3,1]
C0023911
UMLS CUI [3,2]
C1518988
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Similar models

Eligibility Breast Neoplasms NCT01437865

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Lymph nodes TNM clinical staging
Item
1. patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
boolean
C0853879 (UMLS CUI [1])
C0024204 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Neoplasm TNM Breast tumor staging
Item
2. tumor must be a t2 according the tnm 6-classification.
boolean
C0027651 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Axilla Ultrasound | Secondary malignant neoplasm of lymph node Suspected
Item
3. the ultrasound of the axilla must be suspect for nodal metastases.
boolean
C4484660 (UMLS CUI [1])
C0686619 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Protocol Compliance
Item
4. willing and able to undergo all study procedures
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
5. has personally provided written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age <18
boolean
C0001779 (UMLS CUI [1])
Prior Chemotherapy
Item
2. history of prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Prior radiation therapy Axilla Area
Item
3. history of prior radiotherapy of the surrounding areas of the axilla.
boolean
C0279134 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
Pregnancy
Item
4. pregnancy
boolean
C0032961 (UMLS CUI [1])
Medical contraindication MRI | Artificial cardiac pacemaker | Aneurysm clip | Claustrophobia Severe
Item
5. contra indications for mri such as pacemaker, aneurysm clips or severe claustrophobia.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0179977 (UMLS CUI [3])
C0008909 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Hypersensitivity Gadofosveset Ingredient | Hypersensitivity Vasovist | Hypersensitivity Ablavar
Item
6. allergy to any of the ingredients of gadofosveset (vasovist® /ablavar®)
boolean
C0020517 (UMLS CUI [1,1])
C1698893 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1743039 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2746922 (UMLS CUI [3,2])
Informed Consent Unable
Item
7. being unable to give informed consent in person
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Renal Insufficiency Severe | Renal Insufficiency Severe chronic | Glomerular Filtration Rate
Item
8. acute or chronic severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2).
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0017654 (UMLS CUI [3])
Renal Insufficiency Severity Any | Etiology Hepatorenal Syndrome | Transplantation of liver perioperative
Item
9. acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
boolean
C1565489 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0019212 (UMLS CUI [2,2])
C0023911 (UMLS CUI [3,1])
C1518988 (UMLS CUI [3,2])
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