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ID

17915

Beschrijving

Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00068068

Link

https://clinicaltrials.gov/show/NCT00068068

Trefwoorden

  1. 08-10-16 08-10-16 -
  2. 08-10-16 08-10-16 -
Geüploaded op

8 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Liver Metastasis NCT00068068

    Eligibility Liver Metastasis NCT00068068

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease.
    Beschrijving

    Lesion of liver Metastatic Due to colorectal disorder | Metastatic Neoplasm Chemotherapy failed | Disease Progression

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053 (Lesion of liver)
    SNOMED
    300331000
    UMLS CUI [1,2]
    C0036525 (Metastatic to)
    SNOMED
    77879006
    UMLS CUI [1,3]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [1,4]
    C2103078 (colorectal disorders)
    UMLS CUI [2,1]
    C2939420 (Metastatic Neoplasm)
    UMLS CUI [2,2]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2,3]
    C0231175 (Failed)
    UMLS CUI [3]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    biopsy proven evidence of colorectal cancer.
    Beschrijving

    Colorectal Carcinoma Evidence of | Biopsy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009402 (Colorectal Carcinoma)
    LOINC
    LA15686-1
    UMLS CUI [1,2]
    C0332120 (Evidence of (contextual qualifier))
    SNOMED
    18669006
    UMLS CUI [2]
    C0005558 (Biopsy)
    SNOMED
    129314006
    LOINC
    LP68311-7
    patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
    Beschrijving

    Lesion Quantity | Lesion size | Lesion Diameter Maximum

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198 (Lesion)
    SNOMED
    52988006
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [2]
    C0449453 (Lesion size)
    SNOMED
    246116008
    UMLS CUI [3,1]
    C0221198 (Lesion)
    SNOMED
    52988006
    UMLS CUI [3,2]
    C1301886 (Diameter (qualifier value))
    SNOMED
    81827009
    LOINC
    LP66948-8
    UMLS CUI [3,3]
    C0806909 (Maximum)
    SNOMED
    398303009
    LOINC
    LP75983-4
    age greater than or equal to 18 years.
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    patients must be able to sign informed consent.
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    life expectancy greater than or equal to 3 months.
    Beschrijving

    Life Expectancy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    ecog performance status 0-2.
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following litx therapy.
    Beschrijving

    Disease Extrahepatic | Secondary malignant neoplasm of liver | systemic therapy Disease Extrahepatic | Therapies, Investigational

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C1517058 (Extrahepatic)
    UMLS CUI [2]
    C0494165 (Secondary malignant neoplasm of liver)
    SNOMED
    94381002
    UMLS CUI [3,1]
    C1515119 (Systemic Therapy)
    UMLS CUI [3,2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [3,3]
    C1517058 (Extrahepatic)
    UMLS CUI [4]
    C0949266 (Therapies, Investigational)
    off chemotherapy for 4 weeks. must have recovered from the chemotherapy effects.
    Beschrijving

    Chemotherapy ended | Chemotherapy Effects Patients Recovered

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [1,2]
    C2746065 (Stop (qualifier value))
    SNOMED
    422117008
    UMLS CUI [2,1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2,2]
    C1280500 (Effect)
    SNOMED
    253861007
    UMLS CUI [2,3]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [2,4]
    C0521108 (Recovering from)
    SNOMED
    74822006
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients must be excluded if any of the following apply:
    Beschrijving

    Patients Excluded

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C2828389 (Exclusion)
    patients who are candidates for complete surgical resection.
    Beschrijving

    Indication Complete excision

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0015250 (Complete excision)
    SNOMED
    79095000
    pregnancy or breast-feeding. a negative pregnancy test (urine or serum) is required prior to enrollment.
    Beschrijving

    Pregnancy | Breast Feeding | Urine pregnancy test negative Patient need for | Serum pregnancy test negative Patient need for

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [3,1]
    C0430057 (Urine pregnancy test negative)
    SNOMED
    167254001
    UMLS CUI [3,2]
    C0686904 (Patient need for (contextual qualifier))
    SNOMED
    103325001
    UMLS CUI [4,1]
    C0430061 (Serum pregnancy test negative)
    SNOMED
    166435006
    UMLS CUI [4,2]
    C0686904 (Patient need for (contextual qualifier))
    SNOMED
    103325001
    known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
    Beschrijving

    Allergic Reaction Serious Uncontrolled Contrast Media Investigational | anaphylaxis Contrast Media Investigational

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304 (Allergic Reaction)
    SNOMED
    419076005
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    UMLS CUI [1,3]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [1,4]
    C0009924 (Contrast Media)
    SNOMED
    385420005
    LOINC
    LP266908-5
    UMLS CUI [1,5]
    C1517586 (Investigational)
    UMLS CUI [2,1]
    C0002792 (anaphylaxis)
    SNOMED
    39579001
    UMLS CUI [2,2]
    C0009924 (Contrast Media)
    SNOMED
    385420005
    LOINC
    LP266908-5
    UMLS CUI [2,3]
    C1517586 (Investigational)
    pt or ptt greater than 1.5x control.
    Beschrijving

    Prothrombin time | Partial Thromboplastin Time measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0033707 (Prothrombin time assay)
    SNOMED
    396451008
    UMLS CUI [2]
    C0030605 (Activated Partial Thromboplastin Time measurement)
    SNOMED
    42525009
    platelet count less than 100,000.
    Beschrijving

    Platelet Count measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    wbc less than 2500/mm.
    Beschrijving

    White Blood Cell Count procedure

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    neutrophils less than 2000/mm.
    Beschrijving

    Absolute neutrophil count

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    hemoglobin less than 9 g/dl.
    Beschrijving

    Hemoglobin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019046 (Hemoglobin)
    SNOMED
    38082009
    LOINC
    LP32067-8
    liver enzymes greater than 3 x uln.
    Beschrijving

    liver enzymes

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1287351 (Finding of liver enzyme levels)
    SNOMED
    365769003
    total bilirubin greater than 1.5 x uln.
    Beschrijving

    Serum total bilirubin measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    serum creatinine greater than 2.5 x uln.
    Beschrijving

    Creatinine measurement, serum

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003

    Similar models

    Eligibility Liver Metastasis NCT00068068

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Lesion of liver Metastatic Due to colorectal disorder | Metastatic Neoplasm Chemotherapy failed | Disease Progression
    Item
    patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease.
    boolean
    C0577053 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678226 (UMLS CUI [1,3])
    C2103078 (UMLS CUI [1,4])
    C2939420 (UMLS CUI [2,1])
    C0392920 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    C0242656 (UMLS CUI [3])
    Colorectal Carcinoma Evidence of | Biopsy
    Item
    biopsy proven evidence of colorectal cancer.
    boolean
    C0009402 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [2])
    Lesion Quantity | Lesion size | Lesion Diameter Maximum
    Item
    patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
    boolean
    C0221198 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0449453 (UMLS CUI [2])
    C0221198 (UMLS CUI [3,1])
    C1301886 (UMLS CUI [3,2])
    C0806909 (UMLS CUI [3,3])
    Age
    Item
    age greater than or equal to 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    patients must be able to sign informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy greater than or equal to 3 months.
    boolean
    C0023671 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0-2.
    boolean
    C1520224 (UMLS CUI [1])
    Disease Extrahepatic | Secondary malignant neoplasm of liver | systemic therapy Disease Extrahepatic | Therapies, Investigational
    Item
    patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following litx therapy.
    boolean
    C0012634 (UMLS CUI [1,1])
    C1517058 (UMLS CUI [1,2])
    C0494165 (UMLS CUI [2])
    C1515119 (UMLS CUI [3,1])
    C0012634 (UMLS CUI [3,2])
    C1517058 (UMLS CUI [3,3])
    C0949266 (UMLS CUI [4])
    Chemotherapy ended | Chemotherapy Effects Patients Recovered
    Item
    off chemotherapy for 4 weeks. must have recovered from the chemotherapy effects.
    boolean
    C0392920 (UMLS CUI [1,1])
    C2746065 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [2,1])
    C1280500 (UMLS CUI [2,2])
    C0030705 (UMLS CUI [2,3])
    C0521108 (UMLS CUI [2,4])
    Item Group
    C0680251 (UMLS CUI)
    Patients Excluded
    Item
    patients must be excluded if any of the following apply:
    boolean
    C0030705 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    Indication Complete excision
    Item
    patients who are candidates for complete surgical resection.
    boolean
    C3146298 (UMLS CUI [1,1])
    C0015250 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding | Urine pregnancy test negative Patient need for | Serum pregnancy test negative Patient need for
    Item
    pregnancy or breast-feeding. a negative pregnancy test (urine or serum) is required prior to enrollment.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0430057 (UMLS CUI [3,1])
    C0686904 (UMLS CUI [3,2])
    C0430061 (UMLS CUI [4,1])
    C0686904 (UMLS CUI [4,2])
    Allergic Reaction Serious Uncontrolled Contrast Media Investigational | anaphylaxis Contrast Media Investigational
    Item
    known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
    boolean
    C1527304 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    C0009924 (UMLS CUI [1,4])
    C1517586 (UMLS CUI [1,5])
    C0002792 (UMLS CUI [2,1])
    C0009924 (UMLS CUI [2,2])
    C1517586 (UMLS CUI [2,3])
    Prothrombin time | Partial Thromboplastin Time measurement
    Item
    pt or ptt greater than 1.5x control.
    boolean
    C0033707 (UMLS CUI [1])
    C0030605 (UMLS CUI [2])
    Platelet Count measurement
    Item
    platelet count less than 100,000.
    boolean
    C0032181 (UMLS CUI [1])
    White Blood Cell Count procedure
    Item
    wbc less than 2500/mm.
    boolean
    C0023508 (UMLS CUI [1])
    Absolute neutrophil count
    Item
    neutrophils less than 2000/mm.
    boolean
    C0948762 (UMLS CUI [1])
    Hemoglobin
    Item
    hemoglobin less than 9 g/dl.
    boolean
    C0019046 (UMLS CUI [1])
    liver enzymes
    Item
    liver enzymes greater than 3 x uln.
    boolean
    C1287351 (UMLS CUI [1])
    Serum total bilirubin measurement
    Item
    total bilirubin greater than 1.5 x uln.
    boolean
    C1278039 (UMLS CUI [1])
    Creatinine measurement, serum
    Item
    serum creatinine greater than 2.5 x uln.
    boolean
    C0201976 (UMLS CUI [1])

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