0 Avaliações
ID

16432

Descrição

A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00989638

Link

https://clinicaltrials.gov/show/NCT00989638

Palavras-chave

Versões (3)
  1. 16/07/2016 16/07/2016 -
  2. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
  3. 17/11/2021 17/11/2021 -
Transferido a

16 de julho de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Breast Cancer NCT00989638

    Inglês

    Eligibility Breast Cancer NCT00989638

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    known brca1 or brca2 carrier (regardless of age)
    Descrição

    brca1 or brca2 carrier

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3899965
    UMLS CUI [2]
    C3899964
    any mutation carrier in hereditary breast cancer susceptibility genes that is known to increase the risk for breast cancer (regardless of age). some examples of these would include tp53, pten, brca1 and brca2, chek2, atm, and cdh1.
    Descrição

    mutation carrier in hereditary breast cancer susceptibility genes

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2985478
    UMLS CUI [1,2]
    C0346153
    for women who chose not to have genetic testing or test negative, probability of being a brca1 or brca2 carrier of 20% or greater based on brcapro analysis or ≥ 25% risk of being a mutation carrier by couch model in addition to a lifetime breast cancer risk >=20% by gail, care, or claus model
    Descrição

    Risk of BRCA Mutation and breast cancer risk

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1879774
    UMLS CUI [1,2]
    C1512362
    UMLS CUI [2]
    C1707405
    UMLS CUI [3]
    C1511297
    personal history of breast cancer before age 35 years
    Descrição

    personal history of breast cancer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006142
    UMLS CUI [1,2]
    C0262926
    any woman of african ancestry whose 1st degree relative (mother or sister) or 2nd degree relative (aunt, grandmother) if paternal lineage suspected diagnosed with breast cancer under age 40, regardless of risk calculation
    Descrição

    Family history of breast cancer in African ancestry group

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1257891
    UMLS CUI [2]
    C0559119
    have a personal history of ductal carcinoma in situ (dcis) diagnosed at or before age 35 and a first degree relative who had been diagnosed with breast cancer before age 50 or has a first degree relative diagnosed with ovarian cancer at any age
    Descrição

    ductal carcinoma in situ (dis), family history of breast cancer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007124
    UMLS CUI [2]
    C0559119
    any female cancer survivor who received chest irradiation before age 30 for any disease including hodgkin's, a sarcoma, neuroblastoma, or other medical condition.
    Descrição

    chest irradiation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4038705
    UMLS CUI [2]
    C0019829
    UMLS CUI [3]
    C0027819
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    women will be excluded if they meet one of the following:
    Descrição

    Exclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    active cancer at the time of enrollment. a prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
    Descrição

    active cancer or disease free breast cancer in history

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205177
    UMLS CUI [2,1]
    C0242793
    UMLS CUI [2,2]
    C0006142
    current pregnancy
    Descrição

    current pregnancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    presence of a pacemaker or any other metallic foreign objects in their body that interferes with an mri
    Descrição

    pacemaker or metallic foreign object

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0030163
    UMLS CUI [2]
    C1720389
    breast surgery within two weeks of study entry
    Descrição

    breast surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3714726
    previous bilateral mastectomy (prophylactic or therapeutic)
    Descrição

    bilateral mastectomy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0191877
    history of kidney disease or abnormal kidney tests
    Descrição

    kidney disease or abnormal kidney tests

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    UMLS CUI [2]
    C0745526
    women who test negative in a family with identifiable brca mutations are ineligible regardless of risk calculation
    Descrição

    BRCA Test negative

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1445907
    UMLS CUI [1,2]
    | C1445910
    Voltar ao início da página

    Similar models

    Eligibility Breast Cancer NCT00989638

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    brca1 or brca2 carrier
    Item
    known brca1 or brca2 carrier (regardless of age)
    boolean
    C3899965 (UMLS CUI [1])
    C3899964 (UMLS CUI [2])
    mutation carrier in hereditary breast cancer susceptibility genes
    Item
    any mutation carrier in hereditary breast cancer susceptibility genes that is known to increase the risk for breast cancer (regardless of age). some examples of these would include tp53, pten, brca1 and brca2, chek2, atm, and cdh1.
    boolean
    C2985478 (UMLS CUI [1,1])
    C0346153 (UMLS CUI [1,2])
    Risk of BRCA Mutation and breast cancer risk
    Item
    for women who chose not to have genetic testing or test negative, probability of being a brca1 or brca2 carrier of 20% or greater based on brcapro analysis or ≥ 25% risk of being a mutation carrier by couch model in addition to a lifetime breast cancer risk >=20% by gail, care, or claus model
    boolean
    C1879774 (UMLS CUI [1,1])
    C1512362 (UMLS CUI [1,2])
    C1707405 (UMLS CUI [2])
    C1511297 (UMLS CUI [3])
    personal history of breast cancer
    Item
    personal history of breast cancer before age 35 years
    boolean
    C0006142 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Family history of breast cancer in African ancestry group
    Item
    any woman of african ancestry whose 1st degree relative (mother or sister) or 2nd degree relative (aunt, grandmother) if paternal lineage suspected diagnosed with breast cancer under age 40, regardless of risk calculation
    boolean
    C1257891 (UMLS CUI [1])
    C0559119 (UMLS CUI [2])
    ductal carcinoma in situ (dis), family history of breast cancer
    Item
    have a personal history of ductal carcinoma in situ (dcis) diagnosed at or before age 35 and a first degree relative who had been diagnosed with breast cancer before age 50 or has a first degree relative diagnosed with ovarian cancer at any age
    boolean
    C0007124 (UMLS CUI [1])
    C0559119 (UMLS CUI [2])
    chest irradiation
    Item
    any female cancer survivor who received chest irradiation before age 30 for any disease including hodgkin's, a sarcoma, neuroblastoma, or other medical condition.
    boolean
    C4038705 (UMLS CUI [1])
    C0019829 (UMLS CUI [2])
    C0027819 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion criteria
    Item
    women will be excluded if they meet one of the following:
    boolean
    C0680251 (UMLS CUI [1])
    active cancer or disease free breast cancer in history
    Item
    active cancer at the time of enrollment. a prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    C0242793 (UMLS CUI [2,1])
    C0006142 (UMLS CUI [2,2])
    current pregnancy
    Item
    current pregnancy
    boolean
    C0549206 (UMLS CUI [1])
    pacemaker or metallic foreign object
    Item
    presence of a pacemaker or any other metallic foreign objects in their body that interferes with an mri
    boolean
    C0030163 (UMLS CUI [1])
    C1720389 (UMLS CUI [2])
    breast surgery
    Item
    breast surgery within two weeks of study entry
    boolean
    C3714726 (UMLS CUI [1])
    bilateral mastectomy
    Item
    previous bilateral mastectomy (prophylactic or therapeutic)
    boolean
    C0191877 (UMLS CUI [1])
    kidney disease or abnormal kidney tests
    Item
    history of kidney disease or abnormal kidney tests
    boolean
    C0022658 (UMLS CUI [1])
    C0745526 (UMLS CUI [2])
    BRCA Test negative
    Item
    women who test negative in a family with identifiable brca mutations are ineligible regardless of risk calculation
    boolean
    C1445907 (UMLS CUI [1,1])
    | C1445910 (UMLS CUI [1,2])
    Voltar ao início da página 

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