ID

37944

Descrição

Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01305954

Link

https://clinicaltrials.gov/show/NCT01305954

Palavras-chave

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

See clinicaltrials.gov

Transferido a

2 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01305954

Inglês

Eligibility Breast Cancer NCT01305954

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years of age;
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed stage i-iv breast cancer;
Descrição

Breast Carcinoma TNM Breast tumor staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
ecog performance status 0-3;
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
Descrição

Chemotherapy cycle Neoadjuvant Scheduled | Chemotherapy cycle Adjuvant Scheduled | Chemotherapy cycle Scheduled Neoplasm Metastasis | Disease Newly Diagnosed | Recurrent disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C0205539
UMLS CUI [3,3]
C0027627
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1518321
UMLS CUI [5]
C0277556
growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
Descrição

Growth Factors | Filgrastim | pegfilgrastim

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018284
UMLS CUI [2]
C0210630
UMLS CUI [3]
C1136535
absolute lymphocyte count (alc) > 500 cells/μl as determined by routine cbc with differential;
Descrição

Absolute lymphocyte count | Complete blood count with differential

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3544087
UMLS CUI [2]
C0545131
signed, irb approved written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of acute, active infection;
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
Descrição

Bone Marrow Disease Clonal | MYELODYSPLASTIC SYNDROME | Myeloproliferative disease | Acute leukemia | Chronic leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005956
UMLS CUI [1,2]
C1522642
UMLS CUI [2]
C3463824
UMLS CUI [3]
C0027022
UMLS CUI [4]
C0085669
UMLS CUI [5]
C1279296
other co-morbid illness which would impair ability to participate in the study;
Descrição

Comorbidity Impairing Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C2348568
concurrent experimental therapy (note: concurrent biologic therapy is permitted, provided it is not experimental).
Descrição

Therapy, Investigational | Biological treatment Standard allowed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1442989
UMLS CUI [2,3]
C0683607
prior or current receipt of histone deacetylase (hdac) inhibitors
Descrição

Histone deacetylase inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512474
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Similar models

Eligibility Breast Cancer NCT01305954

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years of age;
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
histologically confirmed stage i-iv breast cancer;
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-3;
boolean
C1520224 (UMLS CUI [1])
Chemotherapy cycle Neoadjuvant Scheduled | Chemotherapy cycle Adjuvant Scheduled | Chemotherapy cycle Scheduled Neoplasm Metastasis | Disease Newly Diagnosed | Recurrent disease
Item
scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
boolean
C1302181 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1302181 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C1302181 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1518321 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5])
Growth Factors | Filgrastim | pegfilgrastim
Item
growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
boolean
C0018284 (UMLS CUI [1])
C0210630 (UMLS CUI [2])
C1136535 (UMLS CUI [3])
Absolute lymphocyte count | Complete blood count with differential
Item
absolute lymphocyte count (alc) > 500 cells/μl as determined by routine cbc with differential;
boolean
C3544087 (UMLS CUI [1])
C0545131 (UMLS CUI [2])
Informed Consent
Item
signed, irb approved written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
presence of acute, active infection;
boolean
C0009450 (UMLS CUI [1])
Bone Marrow Disease Clonal | MYELODYSPLASTIC SYNDROME | Myeloproliferative disease | Acute leukemia | Chronic leukemia
Item
history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
boolean
C0005956 (UMLS CUI [1,1])
C1522642 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2])
C0027022 (UMLS CUI [3])
C0085669 (UMLS CUI [4])
C1279296 (UMLS CUI [5])
Comorbidity Impairing Study Subject Participation Status
Item
other co-morbid illness which would impair ability to participate in the study;
boolean
C0009488 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Therapy, Investigational | Biological treatment Standard allowed
Item
concurrent experimental therapy (note: concurrent biologic therapy is permitted, provided it is not experimental).
boolean
C0949266 (UMLS CUI [1])
C1531518 (UMLS CUI [2,1])
C1442989 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Histone deacetylase inhibitor
Item
prior or current receipt of histone deacetylase (hdac) inhibitors
boolean
C1512474 (UMLS CUI [1])
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