Informações:
Falhas:
ID
38256
Descrição
Gadofosveset for Axillary Staging in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01437865
Link
https://clinicaltrials.gov/show/NCT01437865
Palavras-chave
Versões (1)
- 04/10/2019 04/10/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
4 de outubro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01437865
Eligibility Breast Neoplasms NCT01437865
- StudyEvent: Eligibility
Similar models
Eligibility Breast Neoplasms NCT01437865
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])