0 Avaliações
ID

15669

Descrição

Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects; ODM derived from: https://clinicaltrials.gov/show/NCT02284139

Link

https://clinicaltrials.gov/show/NCT02284139

Palavras-chave

Versões (1)
  1. 07/06/2016 07/06/2016 -
Transferido a

7 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Non-small Cell Lung Cancer NCT02284139

    Inglês

    Eligibility Non-small Cell Lung Cancer NCT02284139

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age: older than 20
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. eastern cooperative oncology group (ecog) performance status 0 -2
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    3. histologically confirmed lung cancer, pancreatic cancer, or colon cancer
    Descrição

    Malignant neoplasm of lung | Pancreatic carcinoma | Malignant tumor of colon

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0242379
    UMLS CUI [2]
    C0235974
    UMLS CUI [3]
    C0007102
    4. patients take egfr inhibitor following the reason
    Descrição

    Epidermal growth factor receptor inhibitor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1443775
    egfr mutation (+) nsclc - adenocarcinoma for 1st line treatment
    Descrição

    EGFR gene mutation Non-Small Cell Lung Carcinoma | Adenocarcinoma First line treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3266992
    UMLS CUI [1,2]
    C0007131
    UMLS CUI [2,1]
    C0001418
    UMLS CUI [2,2]
    C1708063
    nsclc - for ≥ 2nd line treatment
    Descrição

    Non-Small Cell Lung Carcinoma | Second line treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    UMLS CUI [2]
    C1710038
    pancreatic cancer - adenocarcinoma for 1st line treatment with gemcitabine
    Descrição

    Pancreatic carcinoma | Adenocarcinoma First line treatment gemcitabine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0235974
    UMLS CUI [2,1]
    C0001418
    UMLS CUI [2,2]
    C1708063
    UMLS CUI [2,3]
    C0045093
    colon cancer - adenocarcinoma 1st line treatment with irinotecan (folfiri)
    Descrição

    Malignant tumor of colon | Adenocarcinoma First line treatment irinotecan Folinic Acid-Fluorouracil-Irinotecan Regimen

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007102
    UMLS CUI [2,1]
    C0001418
    UMLS CUI [2,2]
    C1708063
    UMLS CUI [2,3]
    C0123931
    UMLS CUI [2,4]
    C1880658
    5. patients who have egfr inhibitor related skin side effects (erse) gr≥2 (ncictc v4.0)
    Descrição

    Skin side effects Due to Epidermal growth factor receptor inhibitor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1123023
    UMLS CUI [1,2]
    C0879626
    UMLS CUI [1,3]
    C0678226
    UMLS CUI [1,4]
    C1443775
    6. a patient with the willingness to comply with the study protocol during the study period and capable of complying with it
    Descrição

    Compliance behavior Study Protocol

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C2348563
    7. a patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
    Descrição

    Informed consent | Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C2348568
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. a patient with previous active or passive immunotherapy
    Descrição

    Prior Immunotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1514461
    2. a pregnant or lactating patient
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    3. a patient of childbearing potential without being tested for pregnancy at baseline for positive. (a postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
    Descrição

    Childbearing Potential | Pregnancy test positive Absent | Postmenopausal state | Amenorrhea Period

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2,1]
    C0240802
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3]
    C0232970
    UMLS CUI [4,1]
    C0002453
    UMLS CUI [4,2]
    C1948053
    4. a patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
    Descrição

    Seizures Uncontrolled | CNS disorder | Mental disorders | Informed Consent Unable | Compliance behavior Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0036572
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0007682
    UMLS CUI [3]
    C0004936
    UMLS CUI [4,1]
    C0021430
    UMLS CUI [4,2]
    C1299582
    UMLS CUI [5,1]
    C1321605
    UMLS CUI [5,2]
    C0439801
    5. a patient with history of dermatologic care (except transient urticaria) within 4 weeks
    Descrição

    Care Dermatologic | Urticaria Transient

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1947933
    UMLS CUI [1,2]
    C0205489
    UMLS CUI [2,1]
    C0042109
    UMLS CUI [2,2]
    C0205374
    6. a patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months
    Descrição

    Heart Diseases | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia | Myocardial Infarction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    UMLS CUI [2]
    C0018802
    UMLS CUI [3,1]
    C1956346
    UMLS CUI [3,2]
    C0231220
    UMLS CUI [4]
    C0003811
    UMLS CUI [5]
    C0027051
    7. a patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
    Descrição

    Pneumonia, Interstitial | Pulmonary Fibrosis Diffused Symptomatic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0206061
    UMLS CUI [2,1]
    C0034069
    UMLS CUI [2,2]
    C0012222
    UMLS CUI [2,3]
    C0231220
    8. organ allogenic transplantation requiring immunosuppressive therapy. any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by case basis prior to enrolling the subject
    Descrição

    Transplantation, Homologous | Therapeutic immunosuppression

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0040739
    UMLS CUI [2]
    C0021079
    9. known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
    Descrição

    Hypersensitivity Investigational New Drugs | intolerance to Investigational New Drugs | Hypersensitivity Chemotherapy Pharmaceutical Preparations | intolerance to Chemotherapy Pharmaceutical Preparations

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C1744706
    UMLS CUI [2,2]
    C0013230
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0392920
    UMLS CUI [3,3]
    C0013227
    UMLS CUI [4,1]
    C1744706
    UMLS CUI [4,2]
    C0392920
    UMLS CUI [4,3]
    C0013227
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    Similar models

    Eligibility Non-small Cell Lung Cancer NCT02284139

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. age: older than 20
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    2. eastern cooperative oncology group (ecog) performance status 0 -2
    boolean
    C1520224 (UMLS CUI [1])
    Malignant neoplasm of lung | Pancreatic carcinoma | Malignant tumor of colon
    Item
    3. histologically confirmed lung cancer, pancreatic cancer, or colon cancer
    boolean
    C0242379 (UMLS CUI [1])
    C0235974 (UMLS CUI [2])
    C0007102 (UMLS CUI [3])
    Epidermal growth factor receptor inhibitor
    Item
    4. patients take egfr inhibitor following the reason
    boolean
    C1443775 (UMLS CUI [1])
    EGFR gene mutation Non-Small Cell Lung Carcinoma | Adenocarcinoma First line treatment
    Item
    egfr mutation (+) nsclc - adenocarcinoma for 1st line treatment
    boolean
    C3266992 (UMLS CUI [1,1])
    C0007131 (UMLS CUI [1,2])
    C0001418 (UMLS CUI [2,1])
    C1708063 (UMLS CUI [2,2])
    Non-Small Cell Lung Carcinoma | Second line treatment
    Item
    nsclc - for ≥ 2nd line treatment
    boolean
    C0007131 (UMLS CUI [1])
    C1710038 (UMLS CUI [2])
    Pancreatic carcinoma | Adenocarcinoma First line treatment gemcitabine
    Item
    pancreatic cancer - adenocarcinoma for 1st line treatment with gemcitabine
    boolean
    C0235974 (UMLS CUI [1])
    C0001418 (UMLS CUI [2,1])
    C1708063 (UMLS CUI [2,2])
    C0045093 (UMLS CUI [2,3])
    Malignant tumor of colon | Adenocarcinoma First line treatment irinotecan Folinic Acid-Fluorouracil-Irinotecan Regimen
    Item
    colon cancer - adenocarcinoma 1st line treatment with irinotecan (folfiri)
    boolean
    C0007102 (UMLS CUI [1])
    C0001418 (UMLS CUI [2,1])
    C1708063 (UMLS CUI [2,2])
    C0123931 (UMLS CUI [2,3])
    C1880658 (UMLS CUI [2,4])
    Skin side effects Due to Epidermal growth factor receptor inhibitor
    Item
    5. patients who have egfr inhibitor related skin side effects (erse) gr≥2 (ncictc v4.0)
    boolean
    C1123023 (UMLS CUI [1,1])
    C0879626 (UMLS CUI [1,2])
    C0678226 (UMLS CUI [1,3])
    C1443775 (UMLS CUI [1,4])
    Compliance behavior Study Protocol
    Item
    6. a patient with the willingness to comply with the study protocol during the study period and capable of complying with it
    boolean
    C1321605 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Informed consent | Study Subject Participation Status
    Item
    7. a patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
    boolean
    C0021430 (UMLS CUI [1])
    C2348568 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Prior Immunotherapy
    Item
    1. a patient with previous active or passive immunotherapy
    boolean
    C1514461 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    2. a pregnant or lactating patient
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Childbearing Potential | Pregnancy test positive Absent | Postmenopausal state | Amenorrhea Period
    Item
    3. a patient of childbearing potential without being tested for pregnancy at baseline for positive. (a postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
    boolean
    C3831118 (UMLS CUI [1])
    C0240802 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0232970 (UMLS CUI [3])
    C0002453 (UMLS CUI [4,1])
    C1948053 (UMLS CUI [4,2])
    Seizures Uncontrolled | CNS disorder | Mental disorders | Informed Consent Unable | Compliance behavior Limited
    Item
    4. a patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
    boolean
    C0036572 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0007682 (UMLS CUI [2])
    C0004936 (UMLS CUI [3])
    C0021430 (UMLS CUI [4,1])
    C1299582 (UMLS CUI [4,2])
    C1321605 (UMLS CUI [5,1])
    C0439801 (UMLS CUI [5,2])
    Care Dermatologic | Urticaria Transient
    Item
    5. a patient with history of dermatologic care (except transient urticaria) within 4 weeks
    boolean
    C1947933 (UMLS CUI [1,1])
    C0205489 (UMLS CUI [1,2])
    C0042109 (UMLS CUI [2,1])
    C0205374 (UMLS CUI [2,2])
    Heart Diseases | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia | Myocardial Infarction
    Item
    6. a patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months
    boolean
    C0018799 (UMLS CUI [1])
    C0018802 (UMLS CUI [2])
    C1956346 (UMLS CUI [3,1])
    C0231220 (UMLS CUI [3,2])
    C0003811 (UMLS CUI [4])
    C0027051 (UMLS CUI [5])
    Pneumonia, Interstitial | Pulmonary Fibrosis Diffused Symptomatic
    Item
    7. a patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
    boolean
    C0206061 (UMLS CUI [1])
    C0034069 (UMLS CUI [2,1])
    C0012222 (UMLS CUI [2,2])
    C0231220 (UMLS CUI [2,3])
    Transplantation, Homologous | Therapeutic immunosuppression
    Item
    8. organ allogenic transplantation requiring immunosuppressive therapy. any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by case basis prior to enrolling the subject
    boolean
    C0040739 (UMLS CUI [1])
    C0021079 (UMLS CUI [2])
    Hypersensitivity Investigational New Drugs | intolerance to Investigational New Drugs | Hypersensitivity Chemotherapy Pharmaceutical Preparations | intolerance to Chemotherapy Pharmaceutical Preparations
    Item
    9. known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C1744706 (UMLS CUI [2,1])
    C0013230 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0392920 (UMLS CUI [3,2])
    C0013227 (UMLS CUI [3,3])
    C1744706 (UMLS CUI [4,1])
    C0392920 (UMLS CUI [4,2])
    C0013227 (UMLS CUI [4,3])
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