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ID

37001

Description

Study for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS; ODM derived from: https://clinicaltrials.gov/show/NCT02449681

Link

https://clinicaltrials.gov/show/NCT02449681

Keywords

Versions (1)
  1. 6/27/19 6/27/19 -
Copyright Holder

See clinicaltrials.gov

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June 27, 2019

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Creative Commons BY 4.0
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    Eligibility Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin NCT02449681

    English

    Eligibility Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin NCT02449681

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    eastern cooperative oncology group (ecog) performance status 0-2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
    Description

    Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of mouth | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of skin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1168401
    UMLS CUI [2]
    C0280313
    UMLS CUI [3]
    C0585362
    UMLS CUI [4]
    C0280321
    UMLS CUI [5]
    C0280324
    UMLS CUI [6]
    C0553723
    for patients with oropharyngeal cancer, p16 status is known or can be determined
    Description

    Oropharyngeal Carcinoma | P16 Status Known

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2349952
    UMLS CUI [2,1]
    C2354136
    UMLS CUI [2,2]
    C0449438
    UMLS CUI [2,3]
    C0205309
    measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
    Description

    Measurable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    acceptable laboratory results as indicated by protocol
    Description

    Laboratory Results

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1254595
    acceptable cardiac function as indicated by protocol
    Description

    Cardiac function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232164
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    received prior egfr tki therapy for recurrent or metastatic scc (e.g., oral egfr tkis such as erlotinib, gefitinib, or afatinib)•family history of long qtc syndrome
    Description

    Epidermal growth factor receptor inhibitor Recurrent squamous cell carcinoma | Epidermal growth factor receptor inhibitor Metastatic squamous cell carcinoma | Epidermal growth factor receptor inhibitor Oral | erlotinib | gefitinib | Afatinib | Family history of long QT syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1443775
    UMLS CUI [1,2]
    C4304995
    UMLS CUI [2,1]
    C1443775
    UMLS CUI [2,2]
    C0334246
    UMLS CUI [3,1]
    C1443775
    UMLS CUI [3,2]
    C1527415
    UMLS CUI [4]
    C1135135
    UMLS CUI [5]
    C1122962
    UMLS CUI [6]
    C2987648
    UMLS CUI [7]
    C3839836
    receiving medication that prolongs qt interval ,with a risk of causing torsades de pointes (tdp), unless ecg meets inclusion criteria while on a stable dose of the medication
    Description

    Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes | Exception ECG Fulfill Inclusion criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C0151878
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [2,3]
    C0040479
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0013798
    UMLS CUI [3,3]
    C1550543
    UMLS CUI [3,4]
    C1512693
    family history of long qtc syndrome
    Description

    Family history of long QT syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3839836
    symptomatic central nervous system (cns) lesions, or cns lesions that require therapy
    Description

    Central nervous system lesion Symptomatic | Central nervous system lesion Treatment required for

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0742468
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2,1]
    C0742468
    UMLS CUI [2,2]
    C0332121
    radiation therapy within 2 weeks prior to the first dose of study medication
    Description

    Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
    Description

    Major surgery | Minor Surgical Procedures

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    UMLS CUI [2]
    C0038904
    concurrent active malignancy requiring systemic treatment
    Description

    Malignant Neoplasms Requirement Systemic therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C1515119
    any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
    Description

    Disease Serious Interferes with Completion of clinical trial | Mental condition Interferes with Completion of clinical trial | Communicable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C0521102
    UMLS CUI [1,4]
    C2732579
    UMLS CUI [2,1]
    C3840291
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C2732579
    UMLS CUI [3]
    C0009450
    pregnant or breast-feeding
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
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    Similar models

    Eligibility Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin NCT02449681

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of mouth | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of skin
    Item
    confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
    boolean
    C1168401 (UMLS CUI [1])
    C0280313 (UMLS CUI [2])
    C0585362 (UMLS CUI [3])
    C0280321 (UMLS CUI [4])
    C0280324 (UMLS CUI [5])
    C0553723 (UMLS CUI [6])
    Oropharyngeal Carcinoma | P16 Status Known
    Item
    for patients with oropharyngeal cancer, p16 status is known or can be determined
    boolean
    C2349952 (UMLS CUI [1])
    C2354136 (UMLS CUI [2,1])
    C0449438 (UMLS CUI [2,2])
    C0205309 (UMLS CUI [2,3])
    Measurable Disease
    Item
    measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
    boolean
    C1513041 (UMLS CUI [1])
    Laboratory Results
    Item
    acceptable laboratory results as indicated by protocol
    boolean
    C1254595 (UMLS CUI [1])
    Cardiac function
    Item
    acceptable cardiac function as indicated by protocol
    boolean
    C0232164 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Epidermal growth factor receptor inhibitor Recurrent squamous cell carcinoma | Epidermal growth factor receptor inhibitor Metastatic squamous cell carcinoma | Epidermal growth factor receptor inhibitor Oral | erlotinib | gefitinib | Afatinib | Family history of long QT syndrome
    Item
    received prior egfr tki therapy for recurrent or metastatic scc (e.g., oral egfr tkis such as erlotinib, gefitinib, or afatinib)•family history of long qtc syndrome
    boolean
    C1443775 (UMLS CUI [1,1])
    C4304995 (UMLS CUI [1,2])
    C1443775 (UMLS CUI [2,1])
    C0334246 (UMLS CUI [2,2])
    C1443775 (UMLS CUI [3,1])
    C1527415 (UMLS CUI [3,2])
    C1135135 (UMLS CUI [4])
    C1122962 (UMLS CUI [5])
    C2987648 (UMLS CUI [6])
    C3839836 (UMLS CUI [7])
    Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes | Exception ECG Fulfill Inclusion criteria
    Item
    receiving medication that prolongs qt interval ,with a risk of causing torsades de pointes (tdp), unless ecg meets inclusion criteria while on a stable dose of the medication
    boolean
    C0013227 (UMLS CUI [1,1])
    C0678227 (UMLS CUI [1,2])
    C0151878 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C0040479 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0013798 (UMLS CUI [3,2])
    C1550543 (UMLS CUI [3,3])
    C1512693 (UMLS CUI [3,4])
    Family history of long QT syndrome
    Item
    family history of long qtc syndrome
    boolean
    C3839836 (UMLS CUI [1])
    Central nervous system lesion Symptomatic | Central nervous system lesion Treatment required for
    Item
    symptomatic central nervous system (cns) lesions, or cns lesions that require therapy
    boolean
    C0742468 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0742468 (UMLS CUI [2,1])
    C0332121 (UMLS CUI [2,2])
    Therapeutic radiology procedure
    Item
    radiation therapy within 2 weeks prior to the first dose of study medication
    boolean
    C1522449 (UMLS CUI [1])
    Major surgery | Minor Surgical Procedures
    Item
    major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
    boolean
    C0679637 (UMLS CUI [1])
    C0038904 (UMLS CUI [2])
    Malignant Neoplasms Requirement Systemic therapy
    Item
    concurrent active malignancy requiring systemic treatment
    boolean
    C0006826 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C1515119 (UMLS CUI [1,3])
    Disease Serious Interferes with Completion of clinical trial | Mental condition Interferes with Completion of clinical trial | Communicable Disease
    Item
    any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0521102 (UMLS CUI [1,3])
    C2732579 (UMLS CUI [1,4])
    C3840291 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C2732579 (UMLS CUI [2,3])
    C0009450 (UMLS CUI [3])
    Pregnancy | Breast Feeding
    Item
    pregnant or breast-feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
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