ID

36566

Descrição

Pilot Study of Gamma H2AX DNA Repair Foci Kinetics in Peripheral Blood Lymphocytes During Prostate Cancer Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01899391

Link

https://clinicaltrials.gov/show/NCT01899391

Palavras-chave

Versões (2)
  1. 17/01/2019 17/01/2019 -
  2. 22/05/2019 22/05/2019 -
Titular dos direitos

University Health Network, Toronto

Transferido a

22 de maio de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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    Gamma H2AX DNA Repair During Prostate Cancer Radiotherapy NCT01899391

    Inglês

    Eligibility Criteria

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS < 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).
    Descrição

    Prostate cancer risk assessment (from TNM, GS and PSA)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0600139
    UMLS CUI [1,2]
    C0086930
    UMLS CUI [2]
    C1515169
    UMLS CUI [3]
    C3203027
    UMLS CUI [4]
    C0201544
    planned for radical RT to the prostate with IMRT planning (79Gy/39 fractions or 60 Gy/20 fractions)
    Descrição

    planned for radical RT to the prostate with IMRT planning

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1301732
    UMLS CUI [1,2]
    C0439807
    UMLS CUI [1,3]
    C0033572
    UMLS CUI [1,4]
    C1512814
    UMLS CUI [2]
    C2169193
    UMLS CUI [3]
    C0454266
    no contraindications to diagnostic CT scanning
    Descrição

    no contraindications to diagnostic CT scanning

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C1301624
    UMLS CUI [1,3]
    C0040405
    prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes
    Descrição

    prostate volume

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1441416
    UMLS CUI [2,1]
    C3827011
    UMLS CUI [2,2]
    C0034896
    UMLS CUI [3,1]
    C3827011
    UMLS CUI [3,2]
    C0005682
    no known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT
    Descrição

    no known DNA repair disorders (e.g. AT, BRCA1/2, Li Fraumeni) or contraindications to radical pelvic RT

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0012899
    UMLS CUI [2,1]
    C0332197
    UMLS CUI [2,2]
    C0241889
    UMLS CUI [2,3]
    C0004135
    UMLS CUI [3,1]
    C0332197
    UMLS CUI [3,2]
    C4543583
    UMLS CUI [4,1]
    C0332197
    UMLS CUI [4,2]
    C0241889
    UMLS CUI [4,3]
    C0085390
    UMLS CUI [5,1]
    C0332197
    UMLS CUI [5,2]
    C0522473
    UMLS CUI [5,3]
    C0439807
    UMLS CUI [5,4]
    C1536155
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    inability to provide informed consent
    Descrição

    inability to provide informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    patient having contraindications to diagnostic CT scan
    Descrição

    contraindications to diagnostic CT scan

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0040405
    patients who have unobtainable data regarding previous therapy and their clinical outcome
    Descrição

    patients with unobtainable data regarding previous therapy and their clinical outcome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2046401
    UMLS CUI [1,2]
    C2114510
    UMLS CUI [2,1]
    C2046401
    UMLS CUI [2,2]
    C2114510
    UMLS CUI [2,3]
    C1547647
    Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study
    Descrição

    Recent diagnostic X-rays or CAT scans

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0043299
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C0040405
    UMLS CUI [2,2]
    C0332185
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    Similar models

    Eligibility Criteria

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Prostate cancer risk assessment (from TNM, GS and PSA)
    Item
    Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS < 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).
    boolean
    C0600139 (UMLS CUI [1,1])
    C0086930 (UMLS CUI [1,2])
    C1515169 (UMLS CUI [2])
    C3203027 (UMLS CUI [3])
    C0201544 (UMLS CUI [4])
    planned for radical RT to the prostate with IMRT planning
    Item
    planned for radical RT to the prostate with IMRT planning (79Gy/39 fractions or 60 Gy/20 fractions)
    boolean
    C1301732 (UMLS CUI [1,1])
    C0439807 (UMLS CUI [1,2])
    C0033572 (UMLS CUI [1,3])
    C1512814 (UMLS CUI [1,4])
    C2169193 (UMLS CUI [2])
    C0454266 (UMLS CUI [3])
    no contraindications to diagnostic CT scanning
    Item
    no contraindications to diagnostic CT scanning
    boolean
    C0332197 (UMLS CUI [1,1])
    C1301624 (UMLS CUI [1,2])
    C0040405 (UMLS CUI [1,3])
    prostate volume
    Item
    prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes
    boolean
    C1441416 (UMLS CUI [1])
    C3827011 (UMLS CUI [2,1])
    C0034896 (UMLS CUI [2,2])
    C3827011 (UMLS CUI [3,1])
    C0005682 (UMLS CUI [3,2])
    no known DNA repair disorders (e.g. AT, BRCA1/2, Li Fraumeni) or contraindications to radical pelvic RT
    Item
    no known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT
    boolean
    C0332197 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0012899 (UMLS CUI [1,3])
    C0332197 (UMLS CUI [2,1])
    C0241889 (UMLS CUI [2,2])
    C0004135 (UMLS CUI [2,3])
    C0332197 (UMLS CUI [3,1])
    C4543583 (UMLS CUI [3,2])
    C0332197 (UMLS CUI [4,1])
    C0241889 (UMLS CUI [4,2])
    C0085390 (UMLS CUI [4,3])
    C0332197 (UMLS CUI [5,1])
    C0522473 (UMLS CUI [5,2])
    C0439807 (UMLS CUI [5,3])
    C1536155 (UMLS CUI [5,4])
    Item Group
    C0680251 (UMLS CUI)
    inability to provide informed consent
    Item
    inability to provide informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    contraindications to diagnostic CT scan
    Item
    patient having contraindications to diagnostic CT scan
    boolean
    C1301624 (UMLS CUI [1,1])
    C0040405 (UMLS CUI [1,2])
    patients with unobtainable data regarding previous therapy and their clinical outcome
    Item
    patients who have unobtainable data regarding previous therapy and their clinical outcome
    boolean
    C2046401 (UMLS CUI [1,1])
    C2114510 (UMLS CUI [1,2])
    C2046401 (UMLS CUI [2,1])
    C2114510 (UMLS CUI [2,2])
    C1547647 (UMLS CUI [2,3])
    Recent diagnostic X-rays or CAT scans
    Item
    Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study
    boolean
    C0043299 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C0040405 (UMLS CUI [2,1])
    C0332185 (UMLS CUI [2,2])
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