0 Ratings
ID

43691

Description

Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00149565

Link

https://clinicaltrials.gov/show/NCT00149565

Keywords

Versions (2)
  1. 2/24/16 2/24/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hepatocellular Carcinoma NCT00149565

    English

    Eligibility Hepatocellular Carcinoma NCT00149565

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    1. histologically proven hepatocellular carcinoma.
    Description

    hepatocellular carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2239176
    2. hcc underwent curative resection within 6 weeks before registration.
    Description

    surgery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543467
    3. grossly, the resection margin should be > 1 cm.
    Description

    resection margin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0229985
    4. patients must be younger than 70 year-old.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    5. patients must have a performance status of ecog score < 2.
    Description

    ecog

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    6. patients must have adequate liver reservation and adequate hemogram.
    Description

    liver function and hemogram

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0200631
    7. pugh-child‘s score < 7.
    Description

    pugh-child score

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4050412
    8. the serum total bilirubin level are < 2 mg/dl.
    Description

    bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    9. the prothrombin times are < 3 sec above normal control.
    Description

    prothrombin time

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033707
    10. the platelet are > 10 x 104 / mm3.
    Description

    platelets

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005821
    11. the wbc are > 3,000 / mm3.
    Description

    wbc

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    12. patient must have serum creatinine < 1.5 mg/dl
    Description

    creatinine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    13. cardiac function with nyha classification < grade ii
    Description

    nyha

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1275491
    14. known hbv or hcv status.
    Description

    hbv or hcv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    15. signed informed consent.
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    exclusion criteria:
    Description

    ID.16

    Data type

    boolean

    1. patients who have non-curative resection are not eligible.
    Description

    surgery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543467
    2. resected hccs with histologically positive margins are not eligible.
    Description

    resection margins

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0229985
    3. hccs with radiological evidence of portal vein thrombus are not eligible.
    Description

    portal vein thrombus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2239176
    UMLS CUI [2,1]
    C0087086
    UMLS CUI [2,2]
    C0032718
    4. patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
    Description

    steroids or immunosuppressant agents

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038317
    UMLS CUI [2]
    C0021081
    5. patients with advanced second primary malignancy are not eligible.
    Description

    malignancies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    6. patients with pregnacy or breast-feeding are not eligible.
    Description

    pregnant or breast-feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    7. patients with severe cardiopulmonary diseases are not eligible.
    Description

    cardiopulmonary disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    8. patients with clinically significant psychiatric disorder are not eligible.
    Description

    psychiatric disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    9. patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
    Description

    chemotherapy, immuno-therapeutic drugs or steroids within 6 weeks

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3665472
    UMLS CUI [2]
    C0876248
    UMLS CUI [3]
    C0007222
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    Similar models

    Eligibility Hepatocellular Carcinoma NCT00149565

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    hepatocellular carcinoma
    Item
    1. histologically proven hepatocellular carcinoma.
    boolean
    C2239176 (UMLS CUI [1])
    surgery
    Item
    2. hcc underwent curative resection within 6 weeks before registration.
    boolean
    C0543467 (UMLS CUI [1])
    resection margin
    Item
    3. grossly, the resection margin should be > 1 cm.
    boolean
    C0229985 (UMLS CUI [1])
    Age
    Item
    4. patients must be younger than 70 year-old.
    boolean
    C0001779 (UMLS CUI [1])
    ecog
    Item
    5. patients must have a performance status of ecog score < 2.
    boolean
    C1520224 (UMLS CUI [1])
    liver function and hemogram
    Item
    6. patients must have adequate liver reservation and adequate hemogram.
    boolean
    C0232741 (UMLS CUI [1])
    C0200631 (UMLS CUI [2])
    pugh-child score
    Item
    7. pugh-child‘s score < 7.
    boolean
    C4050412 (UMLS CUI [1])
    bilirubin
    Item
    8. the serum total bilirubin level are < 2 mg/dl.
    boolean
    C1278039 (UMLS CUI [1])
    prothrombin time
    Item
    9. the prothrombin times are < 3 sec above normal control.
    boolean
    C0033707 (UMLS CUI [1])
    platelets
    Item
    10. the platelet are > 10 x 104 / mm3.
    boolean
    C0005821 (UMLS CUI [1])
    wbc
    Item
    11. the wbc are > 3,000 / mm3.
    boolean
    C0023508 (UMLS CUI [1])
    creatinine
    Item
    12. patient must have serum creatinine < 1.5 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    nyha
    Item
    13. cardiac function with nyha classification < grade ii
    boolean
    C1275491 (UMLS CUI [1])
    hbv or hcv
    Item
    14. known hbv or hcv status.
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    informed consent
    Item
    15. signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    ID.16
    Item
    exclusion criteria:
    boolean
    surgery
    Item
    1. patients who have non-curative resection are not eligible.
    boolean
    C0543467 (UMLS CUI [1])
    resection margins
    Item
    2. resected hccs with histologically positive margins are not eligible.
    boolean
    C0229985 (UMLS CUI [1])
    portal vein thrombus
    Item
    3. hccs with radiological evidence of portal vein thrombus are not eligible.
    boolean
    C2239176 (UMLS CUI [1])
    C0087086 (UMLS CUI [2,1])
    C0032718 (UMLS CUI [2,2])
    steroids or immunosuppressant agents
    Item
    4. patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
    boolean
    C0038317 (UMLS CUI [1])
    C0021081 (UMLS CUI [2])
    malignancies
    Item
    5. patients with advanced second primary malignancy are not eligible.
    boolean
    C0006826 (UMLS CUI [1])
    pregnant or breast-feeding
    Item
    6. patients with pregnacy or breast-feeding are not eligible.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    cardiopulmonary disease
    Item
    7. patients with severe cardiopulmonary diseases are not eligible.
    boolean
    C0009488 (UMLS CUI [1])
    psychiatric disorder
    Item
    8. patients with clinically significant psychiatric disorder are not eligible.
    boolean
    C0004936 (UMLS CUI [1])
    chemotherapy, immuno-therapeutic drugs or steroids within 6 weeks
    Item
    9. patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
    boolean
    C3665472 (UMLS CUI [1])
    C0876248 (UMLS CUI [2])
    C0007222 (UMLS CUI [3])
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