ID

13640

Beskrivning

Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities; ODM derived from: https://clinicaltrials.gov/show/NCT00001568

Länk

https://clinicaltrials.gov/show/NCT00001568

Nyckelord

  1. 2016-02-22 2016-02-22 -
Uppladdad den

22 februari 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Colorectal Neoplasm NCT00001568

    Eligibility Colorectal Neoplasm NCT00001568

    Criteria
    Beskrivning

    Criteria

    rising serum cea levels greater than 6 on two successive tests.
    Beskrivning

    cea levels

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201933
    resectable residual or recurrent disease. patients in the occult arm (arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. in addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; ct scan of chest/ abdomen/ pelvis with contrast, mri scan, and chest x-ray. patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.
    Beskrivning

    Surgery, residual or recurrent disease, criteria for study groups

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038894
    UMLS CUI [2]
    C0543478
    UMLS CUI [3]
    C0277556
    UMLS CUI [4]
    C0027627
    patients must have an ecog performance status of 0-1.
    Beskrivning

    ecog performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    patients must be willing to return to nih for follow-up.
    Beskrivning

    return to nih for follow-up

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    patients must be able to provide informed consent as demonstrated by the signed consent.
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patients must be 2 or more months from abdominal or thoracic surgery.
    Beskrivning

    surgery

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038894
    no patients with medical contraindication to abdominal exploration.
    Beskrivning

    abdominal exploration

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0085704
    no patients with recurrent disease detected by conventional imaging studies as outlined above. metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.
    Beskrivning

    recurrent disease, metastatic disease outside of the abdominal cavity, body weight

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    UMLS CUI [2]
    C0027627
    UMLS CUI [3]
    C0005910
    no patients with previous injection of murine monoclonal antibodies: human anti-mouse assay (hama) will be performed in patients with prior history of receiving murine monoclonal antibodies.
    Beskrivning

    prior murine monoclonal antibodies, hama test will be performed

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2916903
    UMLS CUI [2]
    C1868744
    no patients that are pregnant or breast feeding.
    Beskrivning

    pregnant or breast feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    patients who are hiv + will be excluded.
    Beskrivning

    hiv

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682

    Similar models

    Eligibility Colorectal Neoplasm NCT00001568

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    cea levels
    Item
    rising serum cea levels greater than 6 on two successive tests.
    boolean
    C0201933 (UMLS CUI [1])
    Surgery, residual or recurrent disease, criteria for study groups
    Item
    resectable residual or recurrent disease. patients in the occult arm (arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. in addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; ct scan of chest/ abdomen/ pelvis with contrast, mri scan, and chest x-ray. patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.
    boolean
    C0038894 (UMLS CUI [1])
    C0543478 (UMLS CUI [2])
    C0277556 (UMLS CUI [3])
    C0027627 (UMLS CUI [4])
    ecog performance status
    Item
    patients must have an ecog performance status of 0-1.
    boolean
    C1520224 (UMLS CUI [1])
    return to nih for follow-up
    Item
    patients must be willing to return to nih for follow-up.
    boolean
    C1321605 (UMLS CUI [1])
    informed consent
    Item
    patients must be able to provide informed consent as demonstrated by the signed consent.
    boolean
    C0021430 (UMLS CUI [1])
    surgery
    Item
    patients must be 2 or more months from abdominal or thoracic surgery.
    boolean
    C0038894 (UMLS CUI [1])
    abdominal exploration
    Item
    no patients with medical contraindication to abdominal exploration.
    boolean
    C0085704 (UMLS CUI [1])
    recurrent disease, metastatic disease outside of the abdominal cavity, body weight
    Item
    no patients with recurrent disease detected by conventional imaging studies as outlined above. metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.
    boolean
    C0277556 (UMLS CUI [1])
    C0027627 (UMLS CUI [2])
    C0005910 (UMLS CUI [3])
    prior murine monoclonal antibodies, hama test will be performed
    Item
    no patients with previous injection of murine monoclonal antibodies: human anti-mouse assay (hama) will be performed in patients with prior history of receiving murine monoclonal antibodies.
    boolean
    C2916903 (UMLS CUI [1])
    C1868744 (UMLS CUI [2])
    pregnant or breast feeding
    Item
    no patients that are pregnant or breast feeding.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    hiv
    Item
    patients who are hiv + will be excluded.
    boolean
    C0019682 (UMLS CUI [1])

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