0 Ratings

ID

17915

Description

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

Keywords

  1. 10/8/16 10/8/16 -
  2. 10/8/16 10/8/16 -
Uploaded on

October 8, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility Liver Metastasis NCT00068068

    Eligibility Liver Metastasis NCT00068068

    Inclusion Criteria
    Description

    Inclusion Criteria

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

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [1,3]
    C0678226
    UMLS CUI [1,4]
    C2103078
    UMLS CUI [2,1]
    C2939420
    UMLS CUI [2,2]
    C0392920
    UMLS CUI [2,3]
    C0231175
    UMLS CUI [3]
    C0242656
    biopsy proven evidence of colorectal cancer.
    Description

    Colorectal Carcinoma Evidence of | Biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009402
    UMLS CUI [1,2]
    C0332120
    UMLS CUI [2]
    C0005558
    patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
    Description

    Lesion Quantity | Lesion size | Lesion Diameter Maximum

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [2]
    C0449453
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C1301886
    UMLS CUI [3,3]
    C0806909
    age greater than or equal to 18 years.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients must be able to sign informed consent.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    life expectancy greater than or equal to 3 months.
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    ecog performance status 0-2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following litx therapy.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1517058
    UMLS CUI [2]
    C0494165
    UMLS CUI [3,1]
    C1515119
    UMLS CUI [3,2]
    C0012634
    UMLS CUI [3,3]
    C1517058
    UMLS CUI [4]
    C0949266
    off chemotherapy for 4 weeks. must have recovered from the chemotherapy effects.
    Description

    Chemotherapy ended | Chemotherapy Effects Patients Recovered

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C2746065
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C1280500
    UMLS CUI [2,3]
    C0030705
    UMLS CUI [2,4]
    C0521108
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients must be excluded if any of the following apply:
    Description

    Patients Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C2828389
    patients who are candidates for complete surgical resection.
    Description

    Indication Complete excision

    Data type

    boolean

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

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C0430057
    UMLS CUI [3,2]
    C0686904
    UMLS CUI [4,1]
    C0430061
    UMLS CUI [4,2]
    C0686904
    known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C0205318
    UMLS CUI [1,4]
    C0009924
    UMLS CUI [1,5]
    C1517586
    UMLS CUI [2,1]
    C0002792
    UMLS CUI [2,2]
    C0009924
    UMLS CUI [2,3]
    C1517586
    pt or ptt greater than 1.5x control.
    Description

    Prothrombin time | Partial Thromboplastin Time measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033707
    UMLS CUI [2]
    C0030605
    platelet count less than 100,000.
    Description

    Platelet Count measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    wbc less than 2500/mm.
    Description

    White Blood Cell Count procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    neutrophils less than 2000/mm.
    Description

    Absolute neutrophil count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    hemoglobin less than 9 g/dl.
    Description

    Hemoglobin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019046
    liver enzymes greater than 3 x uln.
    Description

    liver enzymes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1287351
    total bilirubin greater than 1.5 x uln.
    Description

    Serum total bilirubin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    serum creatinine greater than 2.5 x uln.
    Description

    Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976

    Similar models

    Eligibility Liver Metastasis NCT00068068

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial