ID

35015

Descrição

Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02391194

Link

https://clinicaltrials.gov/show/NCT02391194

Palavras-chave

Versões (1)
  1. 09/02/2019 09/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02391194

Inglês

Eligibility Breast Cancer NCT02391194

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage i-iii, primary invasive carcinoma of the breast
Descrição

Invasive carcinoma of breast TNM Breast tumor staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
primary surgical treatment is planned to be a mastectomy or lumpectomy. sentinel lymph node (ln) biopsy or axillary ln dissection (alnd) is planned as part of the subject's therapy.
Descrição

Mastectomy Planned | Segmental Mastectomy Planned | Sentinel Lymph Node Biopsy Planned | Excision of axillary lymph nodes Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0024885
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0796693
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0193867
UMLS CUI [4,2]
C1301732
eastern cooperative oncology group (ecog) performance status of 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal function
Descrição

Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
lab values (hematology and chemistry) within institution's normal laboratory limits
Descrição

Normal Laboratory Test Result Hematology | Normal Laboratory Test Result Chemistry

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0438214
UMLS CUI [1,2]
C0200627
UMLS CUI [2,1]
C0438214
UMLS CUI [2,2]
C0201682
willing to remain on-site for approximately 24 hours after administration of avb-620 or, if required, stay overnight after the surgical procedure
Descrição

Compliance behavior | Administration AVB-620 | Operative Surgical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C4053678
UMLS CUI [3]
C0543467
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent ipsilateral breast cancer
Descrição

Breast cancer recurrent Ipsilateral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C0441989
prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer
Descrição

Prior Chemotherapy Neoadjuvant Node-positive breast cancer | Biological treatment Node-positive breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C3160887
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C3160887
open surgery in the ipsilateral breast within 1 year of avb-620 administration
Descrição

Open Surgical Procedure Breast Ipsilateral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4283938
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0441989
history of radiation therapy to ipsilateral breast
Descrição

Radiotherapy to breast Ipsilateral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0948310
UMLS CUI [1,2]
C0441989
abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of avb-620 administration
Descrição

Cardiac Arrhythmia Uncontrolled | Cerebrovascular accident | Event Coronary | Heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C1522318
UMLS CUI [4]
C0018801
diagnosis of autoimmune disorders
Descrição

Autoimmune Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
history of drug-related anaphylactic reactions or allergic reactions
Descrição

Anaphylaxis Drug-induced | Drug Allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0458082
UMLS CUI [2]
C0013182
history of renal disease or current evidence of renal disease
Descrição

Kidney Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
history of non-breast cancer
Descrição

Malignant Neoplasms | Exception Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
systemic investigational drug of any kind within 6 weeks of avb-620 administration
Descrição

Investigational New Drugs Systemic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205373
pregnant or breast feeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02391194

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast TNM Breast tumor staging
Item
stage i-iii, primary invasive carcinoma of the breast
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Mastectomy Planned | Segmental Mastectomy Planned | Sentinel Lymph Node Biopsy Planned | Excision of axillary lymph nodes Planned
Item
primary surgical treatment is planned to be a mastectomy or lumpectomy. sentinel lymph node (ln) biopsy or axillary ln dissection (alnd) is planned as part of the subject's therapy.
boolean
C0024881 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0796693 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0193867 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Normal Laboratory Test Result Hematology | Normal Laboratory Test Result Chemistry
Item
lab values (hematology and chemistry) within institution's normal laboratory limits
boolean
C0438214 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
C0438214 (UMLS CUI [2,1])
C0201682 (UMLS CUI [2,2])
Compliance behavior | Administration AVB-620 | Operative Surgical Procedures
Item
willing to remain on-site for approximately 24 hours after administration of avb-620 or, if required, stay overnight after the surgical procedure
boolean
C1321605 (UMLS CUI [1])
C1533734 (UMLS CUI [2,1])
C4053678 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Breast cancer recurrent Ipsilateral
Item
recurrent ipsilateral breast cancer
boolean
C0278493 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
Prior Chemotherapy Neoadjuvant Node-positive breast cancer | Biological treatment Node-positive breast cancer
Item
prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C3160887 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2,1])
C3160887 (UMLS CUI [2,2])
Open Surgical Procedure Breast Ipsilateral
Item
open surgery in the ipsilateral breast within 1 year of avb-620 administration
boolean
C4283938 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
Radiotherapy to breast Ipsilateral
Item
history of radiation therapy to ipsilateral breast
boolean
C0948310 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
Cardiac Arrhythmia Uncontrolled | Cerebrovascular accident | Event Coronary | Heart failure
Item
abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of avb-620 administration
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C1522318 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4])
Autoimmune Diseases
Item
diagnosis of autoimmune disorders
boolean
C0004364 (UMLS CUI [1])
Anaphylaxis Drug-induced | Drug Allergy
Item
history of drug-related anaphylactic reactions or allergic reactions
boolean
C0002792 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])
Kidney Disease
Item
history of renal disease or current evidence of renal disease
boolean
C0022658 (UMLS CUI [1])
Malignant Neoplasms | Exception Breast Carcinoma
Item
history of non-breast cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Investigational New Drugs Systemic
Item
systemic investigational drug of any kind within 6 weeks of avb-620 administration
boolean
C0013230 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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