ID

38256

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01437865

Stichworte

Versionen (1)
  1. 04.10.19 04.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Oktober 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Neoplasms NCT01437865

Englisch

Eligibility Breast Neoplasms NCT01437865

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Invasive carcinoma of breast | Lymph nodes TNM clinical staging

Datentyp

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.
Beschreibung

Neoplasm TNM Breast tumor staging

Datentyp

boolean

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

Axilla Ultrasound | Secondary malignant neoplasm of lymph node Suspected

Datentyp

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
Beschreibung

Protocol Compliance

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age <18
Beschreibung

Age

Datentyp

boolean

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

Prior Chemotherapy

Datentyp

boolean

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

Prior radiation therapy Axilla Area

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

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

Datentyp

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®)
Beschreibung

Hypersensitivity Gadofosveset Ingredient | Hypersensitivity Vasovist | Hypersensitivity Ablavar

Datentyp

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
Beschreibung

Informed Consent Unable

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Neoplasms NCT01437865

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video