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ID

16432

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00989638

Keywords

versioni (3)
  1. 16/07/16 16/07/16 -
  2. 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
  3. 17/11/21 17/11/21 -
Caricato su

16 luglio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Breast Cancer NCT00989638

    Inglese

    Eligibility Breast Cancer NCT00989638

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

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

    brca1 or brca2 carrier

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3899965 (BRCA1 Mutation Carrier)
    UMLS CUI [2]
    C3899964 (BRCA2 Mutation Carrier)
    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.
    Descrizione

    mutation carrier in hereditary breast cancer susceptibility genes

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2985478 (Mutation Carrier)
    UMLS CUI [1,2]
    C0346153 (Breast Cancer, Familial)
    SNOMED
    254843006
    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
    Descrizione

    Risk of BRCA Mutation and breast cancer risk

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1879774 (BRCAPRO)
    LOINC
    LA20167-5
    UMLS CUI [1,2]
    C1512362 (Heightened Cancer Risk)
    UMLS CUI [2]
    C1707405 (Claus Model)
    SNOMED
    717129004
    UMLS CUI [3]
    C1511297 (Breast Cancer Risk Assessment Tool)
    SNOMED
    717130009
    personal history of breast cancer before age 35 years
    Descrizione

    personal history of breast cancer

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0006142 (Malignant neoplasm of breast)
    SNOMED
    254837009
    UMLS CUI [1,2]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    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
    Descrizione

    Family history of breast cancer in African ancestry group

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1257891 (African Continental Ancestry Group)
    UMLS CUI [2]
    C0559119 (Family history of breast cancer)
    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
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0007124 (Noninfiltrating Intraductal Carcinoma)
    SNOMED
    86616005
    LOINC
    LP57573-5
    UMLS CUI [2]
    C0559119 (Family history of breast cancer)
    any female cancer survivor who received chest irradiation before age 30 for any disease including hodgkin's, a sarcoma, neuroblastoma, or other medical condition.
    Descrizione

    chest irradiation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C4038705 (Radiotherapy to thorax)
    SNOMED
    711299007
    UMLS CUI [2]
    C0019829 (Hodgkin Disease)
    SNOMED
    14537002
    UMLS CUI [3]
    C0027819 (Neuroblastoma)
    SNOMED
    432328008
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    women will be excluded if they meet one of the following:
    Descrizione

    Exclusion criteria

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    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.
    Descrizione

    active cancer or disease free breast cancer in history

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C0205177 (Active)
    SNOMED
    55561003
    LOINC
    LA16666-2
    UMLS CUI [2,1]
    C0242793 (Disease-Free Survival)
    UMLS CUI [2,2]
    C0006142 (Malignant neoplasm of breast)
    SNOMED
    254837009
    current pregnancy
    Descrizione

    current pregnancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    presence of a pacemaker or any other metallic foreign objects in their body that interferes with an mri
    Descrizione

    pacemaker or metallic foreign object

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0030163 (Artificial cardiac pacemaker)
    SNOMED
    14106009
    LOINC
    LP31558-7
    UMLS CUI [2]
    C1720389 (Metallic foreign body)
    SNOMED
    422321007
    breast surgery within two weeks of study entry
    Descrizione

    breast surgery

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3714726 (Operation on breast)
    SNOMED
    392090004
    previous bilateral mastectomy (prophylactic or therapeutic)
    Descrizione

    bilateral mastectomy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0191877 (Bilateral mastectomy)
    SNOMED
    27865001
    history of kidney disease or abnormal kidney tests
    Descrizione

    kidney disease or abnormal kidney tests

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0022658 (Kidney Diseases)
    SNOMED
    90708001
    UMLS CUI [2]
    C0745526 (KIDNEY TEST ABNORMAL)
    women who test negative in a family with identifiable brca mutations are ineligible regardless of risk calculation
    Descrizione

    BRCA Test negative

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1445907 (BRCA1 gene mutation negative)
    SNOMED
    412736006
    UMLS CUI [1,2]
    | C1445910 (undefined)
    Ritorna all'inizio della pagina

    Similar models

    Eligibility Breast Cancer NCT00989638

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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])
    Ritorna all'inizio della pagina 

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