0 Avaliações

ID

14872

Descrição

Vaccination of High Risk Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02229084

Link

https://clinicaltrials.gov/show/NCT02229084

Palavras-chave

  1. 02/05/2016 02/05/2016 -
Transferido a

2 de maio de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Breast Neoplasms NCT02229084

    Eligibility Breast Neoplasms NCT02229084

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    females of all races with clinical stage i, ii, or iii er-positive breast cancer who qualify for standard neoadjuvant treatment
    Descrição

    Gender | Racial group | Estrogen receptor positive status [ER+] Breast Carcinoma | Tumor Stage Classification | Neoadjuvant Therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0034510
    UMLS CUI [3,1]
    C1719706
    UMLS CUI [3,2]
    C0678222
    UMLS CUI [4]
    C0178759
    UMLS CUI [5]
    C0600558
    age 18 years and older
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog performance status 0 or 1.
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    white blood cell (wbc) count ≥ 3,000/mm3 within 2 weeks prior to registration.
    Descrição

    White Blood Cell Count procedure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
    Descrição

    Platelet Count measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    serum glutamic-oxaloacetic transaminase (sgot) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
    Descrição

    SGOT - Glutamate oxaloacetate transaminase | Upper Limit of Normal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0242192
    UMLS CUI [2]
    C1519815
    aspartate aminotransferase test (ast) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
    Descrição

    Aspartate aminotransferase measurement | Upper Limit of Normal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C1519815
    bilirubin ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
    Descrição

    Bilirubin, total measurement | Upper Limit of Normal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201913
    UMLS CUI [2]
    C1519815
    serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
    Descrição

    Creatinine measurement, serum

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    must sign an informed consent approved by the uams institutional review board (irb).
    Descrição

    Informed Consent Institutional Review Board Approval

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2346499
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    active infection requiring treatment with antibiotics.
    Descrição

    Communicable Diseases Requirement Antibiotic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0338237
    diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
    Descrição

    Organic brain syndrome | Study Subject Participation Status Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0029221
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C0439801
    diagnosis or evidence of significant impairment of basal cognitive function that might preclude participation in the full protocol.
    Descrição

    Impaired cognition | Study Subject Participation Status Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0338656
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C0439801
    no other current malignancies. subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or clark i melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
    Descrição

    Malignant Neoplasms | In situ cancer | Lobular carcinoma in situ of breast | Carcinoma in situ of uterine cervix | Atypical melanocytic hyperplasia | Clark melanoma level 1 | Basal cell carcinoma | Squamous cell carcinoma of skin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0851135
    UMLS CUI [3]
    C0279563
    UMLS CUI [4]
    C0851140
    UMLS CUI [5]
    C1265952
    UMLS CUI [6]
    C0205598
    UMLS CUI [7]
    C0007117
    UMLS CUI [8]
    C0553723
    autoimmune disorders or conditions of immunosuppression. this includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. replacement doses of steroids for subjects with adrenal insufficiency are allowed.
    Descrição

    Autoimmune Diseases | Immune System and Related Disorders | Therapeutic procedure | Adrenal Cortex Hormones | Prednisone | Dexamethasone | Antiemetics | Steroid Cream

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2]
    C1334156
    UMLS CUI [3]
    C0087111
    UMLS CUI [4]
    C0001617
    UMLS CUI [5]
    C0032952
    UMLS CUI [6]
    C0011777
    UMLS CUI [7]
    C0003297
    UMLS CUI [8]
    C2985380
    pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study drug and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. accepted methods of contraception include oral contraceptives, barrier methods, iuds, and abstinence.
    Descrição

    Pregnancy | Breast Feeding | Vaccines, Peptide | Childbearing Potential Urine pregnancy test negative Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraception, Barrier | Intrauterine Devices

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0599934
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0430057
    UMLS CUI [4,3]
    C0700589
    UMLS CUI [5]
    C0036899
    UMLS CUI [6]
    C0009905
    UMLS CUI [7]
    C0004764
    UMLS CUI [8]
    C0021900
    any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.
    Descrição

    Other medical condition | Mental disorders | Compliance behavior Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3843040
    UMLS CUI [2]
    C0004936
    UMLS CUI [3,1]
    C1321605
    UMLS CUI [3,2]
    C0439801

    Similar models

    Eligibility Breast Neoplasms NCT02229084

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Racial group | Estrogen receptor positive status [ER+] Breast Carcinoma | Tumor Stage Classification | Neoadjuvant Therapy
    Item
    females of all races with clinical stage i, ii, or iii er-positive breast cancer who qualify for standard neoadjuvant treatment
    boolean
    C0079399 (UMLS CUI [1])
    C0034510 (UMLS CUI [2])
    C1719706 (UMLS CUI [3,1])
    C0678222 (UMLS CUI [3,2])
    C0178759 (UMLS CUI [4])
    C0600558 (UMLS CUI [5])
    Age
    Item
    age 18 years and older
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0 or 1.
    boolean
    C1520224 (UMLS CUI [1])
    White Blood Cell Count procedure
    Item
    white blood cell (wbc) count ≥ 3,000/mm3 within 2 weeks prior to registration.
    boolean
    C0023508 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
    boolean
    C0032181 (UMLS CUI [1])
    SGOT - Glutamate oxaloacetate transaminase | Upper Limit of Normal
    Item
    serum glutamic-oxaloacetic transaminase (sgot) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
    boolean
    C0242192 (UMLS CUI [1])
    C1519815 (UMLS CUI [2])
    Aspartate aminotransferase measurement | Upper Limit of Normal
    Item
    aspartate aminotransferase test (ast) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
    boolean
    C0201899 (UMLS CUI [1])
    C1519815 (UMLS CUI [2])
    Bilirubin, total measurement | Upper Limit of Normal
    Item
    bilirubin ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
    boolean
    C0201913 (UMLS CUI [1])
    C1519815 (UMLS CUI [2])
    Creatinine measurement, serum
    Item
    serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
    boolean
    C0201976 (UMLS CUI [1])
    Informed Consent Institutional Review Board Approval
    Item
    must sign an informed consent approved by the uams institutional review board (irb).
    boolean
    C0021430 (UMLS CUI [1,1])
    C2346499 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Communicable Diseases Requirement Antibiotic therapy
    Item
    active infection requiring treatment with antibiotics.
    boolean
    C0009450 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0338237 (UMLS CUI [1,3])
    Organic brain syndrome | Study Subject Participation Status Limited
    Item
    diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
    boolean
    C0029221 (UMLS CUI [1])
    C2348568 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    Impaired cognition | Study Subject Participation Status Limited
    Item
    diagnosis or evidence of significant impairment of basal cognitive function that might preclude participation in the full protocol.
    boolean
    C0338656 (UMLS CUI [1])
    C2348568 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    Malignant Neoplasms | In situ cancer | Lobular carcinoma in situ of breast | Carcinoma in situ of uterine cervix | Atypical melanocytic hyperplasia | Clark melanoma level 1 | Basal cell carcinoma | Squamous cell carcinoma of skin
    Item
    no other current malignancies. subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or clark i melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
    boolean
    C0006826 (UMLS CUI [1])
    C0851135 (UMLS CUI [2])
    C0279563 (UMLS CUI [3])
    C0851140 (UMLS CUI [4])
    C1265952 (UMLS CUI [5])
    C0205598 (UMLS CUI [6])
    C0007117 (UMLS CUI [7])
    C0553723 (UMLS CUI [8])
    Autoimmune Diseases | Immune System and Related Disorders | Therapeutic procedure | Adrenal Cortex Hormones | Prednisone | Dexamethasone | Antiemetics | Steroid Cream
    Item
    autoimmune disorders or conditions of immunosuppression. this includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. replacement doses of steroids for subjects with adrenal insufficiency are allowed.
    boolean
    C0004364 (UMLS CUI [1])
    C1334156 (UMLS CUI [2])
    C0087111 (UMLS CUI [3])
    C0001617 (UMLS CUI [4])
    C0032952 (UMLS CUI [5])
    C0011777 (UMLS CUI [6])
    C0003297 (UMLS CUI [7])
    C2985380 (UMLS CUI [8])
    Pregnancy | Breast Feeding | Vaccines, Peptide | Childbearing Potential Urine pregnancy test negative Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraception, Barrier | Intrauterine Devices
    Item
    pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study drug and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. accepted methods of contraception include oral contraceptives, barrier methods, iuds, and abstinence.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0599934 (UMLS CUI [3])
    C3831118 (UMLS CUI [4,1])
    C0430057 (UMLS CUI [4,2])
    C0700589 (UMLS CUI [4,3])
    C0036899 (UMLS CUI [5])
    C0009905 (UMLS CUI [6])
    C0004764 (UMLS CUI [7])
    C0021900 (UMLS CUI [8])
    Other medical condition | Mental disorders | Compliance behavior Limited
    Item
    any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.
    boolean
    C3843040 (UMLS CUI [1])
    C0004936 (UMLS CUI [2])
    C1321605 (UMLS CUI [3,1])
    C0439801 (UMLS CUI [3,2])

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