0 Ratings
ID

42799

Description

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of Study: Results - IHC

Link

https://clinicaltrials.gov/ct2/show/NCT00373425

Keywords

Versions (2)
  1. 8/7/16 8/7/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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    IHC Results, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

    English

    IHC Results, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    1 forms  
    Header
    Description

    Header

    Patient's Screening Number
    Description

    Screening number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1710477
    Specimen ID (from Pathology Report)
    Description

    Specimen ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C0370003
    IHC Results
    Description

    IHC Results

    Specimen received: Blocks:
    Description

    Block Specimen

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1533157
    Specimen received: Slides:
    Description

    Specimen

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705201
    Date received
    Description

    Date received

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1514756
    UMLS CUI [1,2]
    C0011008
    Number
    Description

    Number

    Data type

    integer

    Technician
    Description

    Technician

    Data type

    text

    Alias
    UMLS CUI [1]
    C1556020
    Result:
    Description

    IHC Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0021044
    UMLS CUI [1,2]
    C1274040
    Assess the total percentage of tumor cells with membrane stained (any intensity) with EGFr. (% of tumor cells)
    Description

    EGFR membrane staininig in tumor cells

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C0034802
    UMLS CUI [1,2]
    C1704680
    UMLS CUI [1,3]
    C0597032
    %
    Assess the highest intensity of membrane staining in EGFr stained cells.
    Description

    Intensity of membrane staining

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034802
    UMLS CUI [1,2]
    C1704680
    UMLS CUI [1,3]
    C0597032
    UMLS CUI [1,4]
    C0522510
    Assess the percentage of cells displaying the highest intensity of membrane staining. (% of cells at highest intensity)
    Description

    Percentage of cells displaying the highest intensity of membrane staining

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C0034802
    UMLS CUI [1,2]
    C1704680
    UMLS CUI [1,3]
    C0597032
    UMLS CUI [1,4]
    C0522510
    %
    Describe membrane staining as predominantly complete or incomplete.
    Description

    Membrane staining

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034802
    UMLS CUI [1,2]
    C1704680
    UMLS CUI [1,3]
    C0597032
    UMLS CUI [1,4]
    C0007603
    UMLS CUI [1,5]
    C0205197
    Assess the percentage of tumor cells showing only cytoplasmic staining. (% of tumor cells with cytoplasmic staining)
    Description

    Cytoplasmic staining

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C0034802
    UMLS CUI [1,2]
    C1704680
    UMLS CUI [1,3]
    C0597032
    UMLS CUI [1,4]
    C0010834
    %
    Additional Comments
    Description

    Additional Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830770
    Pathologist's Signature
    Description

    Pathologist Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519316
    UMLS CUI [1,2]
    C0334866
    Report Date
    Description

    Report Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302584
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    Similar models

    IHC Results, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Screening number
    Item
    Patient's Screening Number
    integer
    C1710477 (UMLS CUI [1])
    Specimen ID
    Item
    Specimen ID (from Pathology Report)
    text
    C0237753 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C0370003 (UMLS CUI [1,3])
    Item Group
    IHC Results
    Block Specimen
    Item
    Specimen received: Blocks:
    integer
    C1533157 (UMLS CUI [1])
    Specimen
    Item
    Specimen received: Slides:
    integer
    C1705201 (UMLS CUI [1])
    Date received
    Item
    Date received
    date
    C1514756 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Number
    Item
    Number
    integer
    Technician
    Item
    Technician
    text
    C1556020 (UMLS CUI [1])
    Item
    Result:
    integer
    C0021044 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    IHC Result
    Code List
    Result:
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    CL Item
    Undetermined (3)
    EGFR membrane staininig in tumor cells
    Item
    Assess the total percentage of tumor cells with membrane stained (any intensity) with EGFr. (% of tumor cells)
    float
    C0034802 (UMLS CUI [1,1])
    C1704680 (UMLS CUI [1,2])
    C0597032 (UMLS CUI [1,3])
    Item
    Assess the highest intensity of membrane staining in EGFr stained cells.
    integer
    C0034802 (UMLS CUI [1,1])
    C1704680 (UMLS CUI [1,2])
    C0597032 (UMLS CUI [1,3])
    C0522510 (UMLS CUI [1,4])
    Intensity of membrane staining
    Code List
    Assess the highest intensity of membrane staining in EGFr stained cells.
    CL Item
    0, No Staining (1)
    CL Item
    1+, Weak Staining (2)
    CL Item
    2+, Moderate Staining (3)
    CL Item
    3+, Strong Staining (4)
    Percentage of cells displaying the highest intensity of membrane staining
    Item
    Assess the percentage of cells displaying the highest intensity of membrane staining. (% of cells at highest intensity)
    float
    C0034802 (UMLS CUI [1,1])
    C1704680 (UMLS CUI [1,2])
    C0597032 (UMLS CUI [1,3])
    C0522510 (UMLS CUI [1,4])
    Item
    Describe membrane staining as predominantly complete or incomplete.
    integer
    C0034802 (UMLS CUI [1,1])
    C1704680 (UMLS CUI [1,2])
    C0597032 (UMLS CUI [1,3])
    C0007603 (UMLS CUI [1,4])
    C0205197 (UMLS CUI [1,5])
    Membrane staining
    Code List
    Describe membrane staining as predominantly complete or incomplete.
    CL Item
    Complete (1)
    CL Item
    Incomplete (2)
    Cytoplasmic staining
    Item
    Assess the percentage of tumor cells showing only cytoplasmic staining. (% of tumor cells with cytoplasmic staining)
    float
    C0034802 (UMLS CUI [1,1])
    C1704680 (UMLS CUI [1,2])
    C0597032 (UMLS CUI [1,3])
    C0010834 (UMLS CUI [1,4])
    Additional Comments
    Item
    Additional Comments
    text
    C1830770 (UMLS CUI [1])
    Pathologist Signature
    Item
    Pathologist's Signature
    text
    C1519316 (UMLS CUI [1,1])
    C0334866 (UMLS CUI [1,2])
    Report Date
    Item
    Report Date
    date
    C1302584 (UMLS CUI [1])
    Back to the top of the page 

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