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ID

13640

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00001568

Stichworte

  1. 22.02.16 22.02.16 -
Hochgeladen am

22. Februar 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Colorectal Neoplasm NCT00001568

    Eligibility Colorectal Neoplasm NCT00001568

    Criteria
    Beschreibung

    Criteria

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

    cea levels

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201933 (Carcinoembryonic antigen measurement)
    SNOMED
    60267001
    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.
    Beschreibung

    Surgery, residual or recurrent disease, criteria for study groups

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038894 (Surgery specialty)
    UMLS CUI [2]
    C0543478 (Residual Tumor)
    UMLS CUI [3]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    UMLS CUI [4]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    patients must have an ecog performance status of 0-1.
    Beschreibung

    ecog performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    patients must be willing to return to nih for follow-up.
    Beschreibung

    return to nih for follow-up

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    patients must be able to provide informed consent as demonstrated by the signed consent.
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    patients must be 2 or more months from abdominal or thoracic surgery.
    Beschreibung

    surgery

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038894 (Surgery specialty)
    no patients with medical contraindication to abdominal exploration.
    Beschreibung

    abdominal exploration

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0085704 (Exploratory laparotomy)
    SNOMED
    74770008
    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.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    UMLS CUI [2]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [3]
    C0005910 (Body Weight)
    SNOMED
    27113001
    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.
    Beschreibung

    prior murine monoclonal antibodies, hama test will be performed

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2916903 (Antibodies, Monoclonal, Murine-Derived)
    UMLS CUI [2]
    C1868744 (Human anti-mouse antibody test)
    no patients that are pregnant or breast feeding.
    Beschreibung

    pregnant or breast feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    patients who are hiv + will be excluded.
    Beschreibung

    hiv

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1

    Ähnliche Modelle

    Eligibility Colorectal Neoplasm NCT00001568

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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