ID

34974

Descrição

HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02063724

Link

https://clinicaltrials.gov/show/NCT02063724

Palavras-chave

Versões (1)
  1. 06/02/2019 06/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de fevereiro de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Breast Cancer NCT02063724

Inglês

Eligibility Breast Cancer NCT02063724

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
women over age 18 years.
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects with invasive breast cancer at least stage iiia greater than or equal to n2 (4 positive nodes) or have recurrent metastatic breast cancer rendered ned by any means that are classic her-2 3+ 30%, 2+ ihc and fish positive or her-2 2+ fish negative verified by the department of pathology at the hospital of the university of pennsylvania that have completed chemotherapy and/or trastuzumab and are within 1 year from there last treatment and have no evidence of disease.
Descrição

Invasive carcinoma of breast TNM Breast tumor staging | BREAST CANCER METASTATIC RECURRENT | HER2 Status Immunohistochemistry | HER2 Status FISH | Chemotherapy Completed | trastuzumab

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0741681
UMLS CUI [3,1]
C1512413
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C1512413
UMLS CUI [4,2]
C0162789
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0205197
UMLS CUI [6]
C0728747
patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
Descrição

Antioestrogen therapy Breast Carcinoma | Vaccination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0854638
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0042196
women of childbearing age with a negative pregnancy test documented prior to enrollment.
Descrição

Childbearing Potential Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
subjects with ecog performance status score of 0 or 1 (appendix d).
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
subjects willing to use birth control if necessary
Descrição

Contraceptive methods Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with positive hiv or hepatitis c at baseline by report.
Descrição

HIV Seropositivity | Hepatitis C positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112419
subjects with coagulopathies, including thrombocytopenia with platelet count less than 75,000, inr greater than 1.5 and partial thromboplastin time greater than 50 sec
Descrição

Blood Coagulation Disorders | Thrombocytopenia | Platelet Count measurement | International Normalized Ratio | Partial thromboplastin time finding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0040034
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0525032
UMLS CUI [5]
C1531697
subjects with major cardiac illness muga less than 50% ef.
Descrição

Heart Disease Major | Cardiac ejection fraction MUGA

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by pi.
Descrição

Pre-existing condition Interferes with Clinical Trial | Pharmaceutical Preparations Interfere with Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
Voltar ao início da página

Similar models

Eligibility Breast Cancer NCT02063724

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women over age 18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast TNM Breast tumor staging | BREAST CANCER METASTATIC RECURRENT | HER2 Status Immunohistochemistry | HER2 Status FISH | Chemotherapy Completed | trastuzumab
Item
subjects with invasive breast cancer at least stage iiia greater than or equal to n2 (4 positive nodes) or have recurrent metastatic breast cancer rendered ned by any means that are classic her-2 3+ 30%, 2+ ihc and fish positive or her-2 2+ fish negative verified by the department of pathology at the hospital of the university of pennsylvania that have completed chemotherapy and/or trastuzumab and are within 1 year from there last treatment and have no evidence of disease.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0741681 (UMLS CUI [2])
C1512413 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C1512413 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
C0728747 (UMLS CUI [6])
Antioestrogen therapy Breast Carcinoma | Vaccination
Item
patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
boolean
C0854638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative
Item
women of childbearing age with a negative pregnancy test documented prior to enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
ECOG performance status
Item
subjects with ecog performance status score of 0 or 1 (appendix d).
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods Willing
Item
subjects willing to use birth control if necessary
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed Consent
Item
subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | Hepatitis C positive
Item
subjects with positive hiv or hepatitis c at baseline by report.
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Blood Coagulation Disorders | Thrombocytopenia | Platelet Count measurement | International Normalized Ratio | Partial thromboplastin time finding
Item
subjects with coagulopathies, including thrombocytopenia with platelet count less than 75,000, inr greater than 1.5 and partial thromboplastin time greater than 50 sec
boolean
C0005779 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
C1531697 (UMLS CUI [5])
Heart Disease Major | Cardiac ejection fraction MUGA
Item
subjects with major cardiac illness muga less than 50% ef.
boolean
C0018799 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Pre-existing condition Interferes with Clinical Trial | Pharmaceutical Preparations Interfere with Clinical Trial
Item
subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by pi.
boolean
C0521987 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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