ID

38256

Description

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

Lien

https://clinicaltrials.gov/show/NCT01437865

Mots-clés

Versions (1)
  1. 04/10/2019 04/10/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 octobre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Breast Neoplasms NCT01437865

Anglais

Eligibility Breast Neoplasms NCT01437865

1 Formulaires  
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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age <18
Description

Age

Type de données

boolean

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

Prior Chemotherapy

Type de données

boolean

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

Prior radiation therapy Axilla Area

Type de données

boolean

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

Pregnancy

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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
Retour au début de la page

Similar models

Eligibility Breast Neoplasms NCT01437865

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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