0 Ratings

ID

13000

Description

Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00041652

Link

https://clinicaltrials.gov/show/NCT00041652

Keywords

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

January 10, 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 Colorectal Cancer NCT00041652

    Eligibility Colorectal Cancer NCT00041652

    Criteria
    Description

    Criteria

    histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
    Description

    colonic, rectal or breast carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0699790
    UMLS CUI [2]
    C0007113
    UMLS CUI [3]
    C0678222
    measurable lesion diagnosed by ct scan
    Description

    measurable disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0040405
    UMLS CUI [1,2]
    C1513041
    recurrent/metastatic disease considered surgically unresectable.
    Description

    unresectable: relapse, metastasis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0277556
    UMLS CUI [1,2]
    C1519810
    UMLS CUI [2,1]
    C0027627
    UMLS CUI [2,2]
    C1519810
    prior/concurrent therapy:
    Description

    concurrent therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009429
    chemotherapy: patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (enrollment must occur at least 4 weeks beyond last treatment)
    Description

    chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    other: prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study
    Description

    study subject participation status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    performance status: patients with a karnofsky performance status > 70% (or equivalent, ecog 0-1) and expected survival of at least 3 months.
    Description

    karnofsky, ecog, life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    UMLS CUI [2]
    C1520224
    UMLS CUI [3]
    C0023671
    hematopoietic: wbc >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, cea < 300 ng/ml
    Description

    wbc, neutrophils, platelets

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    UMLS CUI [2]
    C0200633
    UMLS CUI [3]
    C0032181
    hepatic: serum bilirubin </= 2.0 mg/dl, alt < 2.5 x iuln
    Description

    bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    cardiovascular: patients with lvef >/= 40% by required muga/2d-echo study.
    Description

    lvef

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    pulmonary: patients with fev1 >/= 60% by required pulmonary function tests
    Description

    fev1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0748133
    other: patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. a pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent. patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.
    Description

    contraception, pregnancy test, informed consent, comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    UMLS CUI [2]
    C0032976
    UMLS CUI [3]
    C0021430
    UMLS CUI [4,1]
    C1321605
    UMLS CUI [4,2]
    C0439801
    UMLS CUI [4,3]
    C0009488

    Similar models

    Eligibility Colorectal Cancer NCT00041652

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    colonic, rectal or breast carcinoma
    Item
    histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
    boolean
    C0699790 (UMLS CUI [1])
    C0007113 (UMLS CUI [2])
    C0678222 (UMLS CUI [3])
    measurable disease
    Item
    measurable lesion diagnosed by ct scan
    boolean
    C0040405 (UMLS CUI [1,1])
    C1513041 (UMLS CUI [1,2])
    unresectable: relapse, metastasis
    Item
    recurrent/metastatic disease considered surgically unresectable.
    boolean
    C0277556 (UMLS CUI [1,1])
    C1519810 (UMLS CUI [1,2])
    C0027627 (UMLS CUI [2,1])
    C1519810 (UMLS CUI [2,2])
    concurrent therapy
    Item
    prior/concurrent therapy:
    boolean
    C0009429 (UMLS CUI [1])
    chemotherapy
    Item
    chemotherapy: patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (enrollment must occur at least 4 weeks beyond last treatment)
    boolean
    C0392920 (UMLS CUI [1])
    study subject participation status
    Item
    other: prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study
    boolean
    C2348568 (UMLS CUI [1])
    karnofsky, ecog, life expectancy
    Item
    performance status: patients with a karnofsky performance status > 70% (or equivalent, ecog 0-1) and expected survival of at least 3 months.
    boolean
    C0206065 (UMLS CUI [1])
    C1520224 (UMLS CUI [2])
    C0023671 (UMLS CUI [3])
    wbc, neutrophils, platelets
    Item
    hematopoietic: wbc >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, cea < 300 ng/ml
    boolean
    C0023508 (UMLS CUI [1])
    C0200633 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    bilirubin
    Item
    hepatic: serum bilirubin </= 2.0 mg/dl, alt < 2.5 x iuln
    boolean
    C1278039 (UMLS CUI [1])
    lvef
    Item
    cardiovascular: patients with lvef >/= 40% by required muga/2d-echo study.
    boolean
    C0428772 (UMLS CUI [1])
    fev1
    Item
    pulmonary: patients with fev1 >/= 60% by required pulmonary function tests
    boolean
    C0748133 (UMLS CUI [1])
    contraception, pregnancy test, informed consent, comorbidity
    Item
    other: patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. a pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent. patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.
    boolean
    C0700589 (UMLS CUI [1])
    C0032976 (UMLS CUI [2])
    C0021430 (UMLS CUI [3])
    C1321605 (UMLS CUI [4,1])
    C0439801 (UMLS CUI [4,2])
    C0009488 (UMLS CUI [4,3])

    Please use this form for feedback, questions and suggestions for improvements.

    Fields marked with * are required.

    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