0 Ratings
ID

42211

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00071084

Link

http://clinicaltrials.gov/ct2/show/record/NCT00071084

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/11/14 4/11/14 - Julian Varghese
  3. 4/11/14 4/11/14 - Julian Varghese
  4. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Criteria NCT00071084

    English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion
    Description

    Inclusion

    Medical diagnosis of CTCL, and positivity for the CD4 receptor. - Late stage CTCL
    Description

    CTCL

    Data type

    boolean

    Have received at least one prior anti-cancer therapy with inadequate effect
    Description

    Prior therapy

    Data type

    boolean

    WHO performance status 0,1 or 2 - Male or female, age 18 or older. - Signed informed consent.
    Description

    Other

    Data type

    boolean

    Exclusion
    Description

    Exclusion

    Certain rare types of CTCL.
    Description

    Rare CTCL

    Data type

    boolean

    Previous treatment with other anti-CD4 medications. - More than two previous treatments with systemic chemotherapy. - Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. - Some types of steroid treatments less than two weeks before entering the trial
    Description

    Previous treatment

    Data type

    boolean

    Prolonged exposure to sunlight or UV light during the trial. - Other cancer diseases, except certain skin cancers or cervix cancer. - Chronic infectious disease requiring medication. - Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. - Certain laboratory values which are too high or too low. - HIV positivity
    Description

    Other

    Data type

    boolean

    Pregnant or breast-feeding women. - Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
    Description

    Pregnancy - Lactation

    Data type

    boolean

    If you are participating in another trial with a different new drug 4 weeks before you enter this trial
    Description

    other trial

    Data type

    boolean

    Medical concepts
    Description

    Medical concepts

    Diagnosis
    Description

    Diagnosis

    Data type

    string

    Alias
    UMLS CUI
    C0011900
    SNOMED CT 2010_0731
    439401001
    Lymphoma, T-Cell, Cutaneous
    Description

    CTCL

    Data type

    string

    Alias
    UMLS CUI
    C0079773
    SNOMED CT 2010_0731
    28054005
    Diagnostic Neoplasm Staging
    Description

    Tumor Staging

    Data type

    string

    Alias
    UMLS CUI
    C0027646
    SNOMED CT 2010_0731
    254292007
    LOINC Version 232
    LP78422-0
    Therapeutic procedure
    Description

    Therapeutic procedure

    Data type

    string

    Alias
    UMLS CUI
    C0087111
    WHO performance status finding
    Description

    WHO performance status finding

    Data type

    string

    Alias
    UMLS CUI
    C1298651
    SNOMED CT 2010_0731
    373802001
    Age
    Description

    Age

    Data type

    string

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    102518004
    Medication
    Description

    Pharmaceutical Preparations

    Data type

    string

    Alias
    UMLS CUI
    C0013227
    Chemotherapy
    Description

    Chemotherapy

    Data type

    string

    Alias
    UMLS CUI
    C0392920
    SNOMED CT 2010_0731
    150415003
    Exposure to sunlight
    Description

    Exposure to sunlight

    Data type

    string

    Alias
    UMLS CUI
    C0497062
    ICD-10-CM Version 2010
    X32
    Infection
    Description

    Infection

    Data type

    string

    Alias
    UMLS CUI
    C0009450
    SNOMED CT 2010_0731
    257551009
    MedDRA 13.1
    10021789
    HIV negative
    Description

    HIV negative

    Data type

    string

    Alias
    UMLS CUI
    C0481430
    SNOMED CT 2010_0731
    143223008
    MedDRA 13.1
    10020179
    pregnant
    Description

    pregnant

    Data type

    string

    Alias
    UMLS CUI
    C0549206
    MedDRA 13.1
    10036586
    Breast feeding
    Description

    Lactation

    Data type

    string

    Alias
    UMLS CUI
    C0006147
    MedDRA 13.1
    10006247
    Contraception
    Description

    Contraception

    Data type

    string

    Alias
    UMLS CUI
    C0700589
    SNOMED CT 2010_0731
    146680009
    MedDRA 13.1
    10010808
    Enrollment
    Description

    Enrollment

    Data type

    string

    Alias
    UMLS CUI
    C2348568
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion
    CTCL
    Item
    Medical diagnosis of CTCL, and positivity for the CD4 receptor. - Late stage CTCL
    boolean
    Prior therapy
    Item
    Have received at least one prior anti-cancer therapy with inadequate effect
    boolean
    Other
    Item
    WHO performance status 0,1 or 2 - Male or female, age 18 or older. - Signed informed consent.
    boolean
    Item Group
    Exclusion
    Rare CTCL
    Item
    Certain rare types of CTCL.
    boolean
    Previous treatment
    Item
    Previous treatment with other anti-CD4 medications. - More than two previous treatments with systemic chemotherapy. - Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. - Some types of steroid treatments less than two weeks before entering the trial
    boolean
    Other
    Item
    Prolonged exposure to sunlight or UV light during the trial. - Other cancer diseases, except certain skin cancers or cervix cancer. - Chronic infectious disease requiring medication. - Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. - Certain laboratory values which are too high or too low. - HIV positivity
    boolean
    Pregnancy - Lactation
    Item
    Pregnant or breast-feeding women. - Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
    boolean
    other trial
    Item
    If you are participating in another trial with a different new drug 4 weeks before you enter this trial
    boolean
    Item Group
    Medical concepts
    Diagnosis
    Item
    Diagnosis
    string
    C0011900 (UMLS CUI)
    439401001 (SNOMED CT 2010_0731)
    CTCL
    Item
    Lymphoma, T-Cell, Cutaneous
    string
    C0079773 (UMLS CUI)
    28054005 (SNOMED CT 2010_0731)
    Tumor Staging
    Item
    Diagnostic Neoplasm Staging
    string
    C0027646 (UMLS CUI)
    254292007 (SNOMED CT 2010_0731)
    LP78422-0 (LOINC Version 232)
    Therapeutic procedure
    Item
    Therapeutic procedure
    string
    C0087111 (UMLS CUI)
    WHO performance status finding
    Item
    WHO performance status finding
    string
    C1298651 (UMLS CUI)
    373802001 (SNOMED CT 2010_0731)
    Age
    Item
    Age
    string
    C0001779 (UMLS CUI)
    102518004 (SNOMED CT 2010_0731)
    Pharmaceutical Preparations
    Item
    Medication
    string
    C0013227 (UMLS CUI)
    Chemotherapy
    Item
    Chemotherapy
    string
    C0392920 (UMLS CUI)
    150415003 (SNOMED CT 2010_0731)
    Exposure to sunlight
    Item
    Exposure to sunlight
    string
    C0497062 (UMLS CUI)
    X32 (ICD-10-CM Version 2010)
    Infection
    Item
    Infection
    string
    C0009450 (UMLS CUI)
    257551009 (SNOMED CT 2010_0731)
    10021789 (MedDRA 13.1)
    HIV negative
    Item
    HIV negative
    string
    C0481430 (UMLS CUI)
    143223008 (SNOMED CT 2010_0731)
    10020179 (MedDRA 13.1)
    pregnant
    Item
    pregnant
    string
    C0549206 (UMLS CUI)
    10036586 (MedDRA 13.1)
    Lactation
    Item
    Breast feeding
    string
    C0006147 (UMLS CUI)
    10006247 (MedDRA 13.1)
    Contraception
    Item
    Contraception
    string
    C0700589 (UMLS CUI)
    146680009 (SNOMED CT 2010_0731)
    10010808 (MedDRA 13.1)
    Enrollment
    Item
    Enrollment
    string
    C2348568 (UMLS CUI)
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