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ID

43946

Descrizione

Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02315469

collegamento

https://clinicaltrials.gov/show/NCT02315469

Keywords

versioni (2)
  1. 19/05/16 19/05/16 -
  2. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

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Licenza

Creative Commons BY 4.0
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    Eligibility Fallopian Tube Carcinoma NCT02315469

    Inglese

    Eligibility Fallopian Tube Carcinoma NCT02315469

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
    Descrizione

    Ovarian Carcinoma | Fallopian Tube Neoplasms | Primary Peritoneal Carcinoma | Papillary carcinoma of uterus Advanced phase | performance status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0029925 (Ovarian Carcinoma)
    UMLS CUI [2]
    C0015558 (Fallopian Tube Neoplasms)
    SNOMED
    126916003
    UMLS CUI [3]
    C1514428 (Primary peritoneal carcinoma)
    UMLS CUI [4,1]
    C0279764 (undefined)
    UMLS CUI [4,2]
    C0205179 (Advanced phase)
    SNOMED
    86005002
    UMLS CUI [5]
    C1518965 (Performance Status)
    patients must have signed an approved informed consent and authorization permitting release of personal health information
    Descrizione

    Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    patients who can understand sufficiently to be able to respond to questions posed by the study instruments
    Descrizione

    Comprehension | Able to respond to communication by others | Study Protocol

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [2]
    C0566155 (Able to respond to communication by others)
    SNOMED
    288732007
    UMLS CUI [3]
    C2348563 (Study Protocol)
    patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire
    Descrizione

    Patients | Caregiver | Consent | Response Questionnaires

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [2]
    C0085537 (Caregiver)
    SNOMED
    133932002
    LOINC
    LP76010-5
    UMLS CUI [3]
    C1511481 (Consent)
    LOINC
    LP100037-3
    UMLS CUI [4,1]
    C2911692 (Response (communication))
    UMLS CUI [4,2]
    C0034394 (Questionnaires)
    note: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
    Descrizione

    Age | Neoadjuvant Therapy Chemotherapy Regimen | Operative Surgical Procedures Interval | Cytoreduction Surgical Procedures

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2,1]
    C0600558 (Neoadjuvant Therapy)
    UMLS CUI [2,2]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [3,1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [3,2]
    C1272706 (Interval)
    SNOMED
    385673002
    UMLS CUI [4]
    C3850079 (Cytoreductive Surgery)
    post-operative pathology will not exclude patients from this study
    Descrizione

    Pathology Postoperative

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0205469 (Pathological aspects)
    UMLS CUI [1,2]
    C0231287 (Postoperative state)
    SNOMED
    19585003
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
    Descrizione

    Life circumstances Compliance behavior Limited

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0680082 (life circumstances)
    UMLS CUI [1,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (mis) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
    Descrizione

    Minimally Invasive Surgical Procedures | Cytoreductive surgery | Ovarian Carcinoma | Fallopian Tube Neoplasms | Malignant tumor of peritoneum | Advanced phase

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0282624 (Minimally Invasive Surgical Procedures)
    UMLS CUI [2]
    C3850079 (Cytoreductive Surgery)
    UMLS CUI [3]
    C0029925 (Ovarian Carcinoma)
    UMLS CUI [4]
    C0015558 (Fallopian Tube Neoplasms)
    SNOMED
    126916003
    UMLS CUI [5]
    C0153467 (Malignant tumor of peritoneum)
    SNOMED
    363492001
    UMLS CUI [6]
    C0205179 (Advanced phase)
    SNOMED
    86005002
    patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
    Descrizione

    Chemotherapy Regimen | Malignant Neoplasms Gynecologic | Geriatric Assessment

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2,2]
    C0205480 (Gynecologic)
    SNOMED
    74570005
    UMLS CUI [3]
    C0017463 (Geriatric Assessment)
    SNOMED
    171313004
    patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy
    Descrizione

    Uterine Cancer Preoperative | Endometrial biopsy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0153567 (Uterine Cancer)
    SNOMED
    371973000
    LOINC
    LA10544-7
    UMLS CUI [1,2]
    C0445204 (Preoperative)
    SNOMED
    262068006
    LOINC
    LP91296-1
    UMLS CUI [2]
    C1510477 (Endometrial biopsy)
    SNOMED
    386802000
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    Similar models

    Eligibility Fallopian Tube Carcinoma NCT02315469

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Ovarian Carcinoma | Fallopian Tube Neoplasms | Primary Peritoneal Carcinoma | Papillary carcinoma of uterus Advanced phase | performance status
    Item
    patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
    boolean
    C0029925 (UMLS CUI [1])
    C0015558 (UMLS CUI [2])
    C1514428 (UMLS CUI [3])
    C0279764 (UMLS CUI [4,1])
    C0205179 (UMLS CUI [4,2])
    C1518965 (UMLS CUI [5])
    Informed Consent
    Item
    patients must have signed an approved informed consent and authorization permitting release of personal health information
    boolean
    C0021430 (UMLS CUI [1])
    Comprehension | Able to respond to communication by others | Study Protocol
    Item
    patients who can understand sufficiently to be able to respond to questions posed by the study instruments
    boolean
    C0162340 (UMLS CUI [1])
    C0566155 (UMLS CUI [2])
    C2348563 (UMLS CUI [3])
    Patients | Caregiver | Consent | Response Questionnaires
    Item
    patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire
    boolean
    C0030705 (UMLS CUI [1])
    C0085537 (UMLS CUI [2])
    C1511481 (UMLS CUI [3])
    C2911692 (UMLS CUI [4,1])
    C0034394 (UMLS CUI [4,2])
    Age | Neoadjuvant Therapy Chemotherapy Regimen | Operative Surgical Procedures Interval | Cytoreduction Surgical Procedures
    Item
    note: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
    boolean
    C0001779 (UMLS CUI [1])
    C0600558 (UMLS CUI [2,1])
    C0392920 (UMLS CUI [2,2])
    C0543467 (UMLS CUI [3,1])
    C1272706 (UMLS CUI [3,2])
    C3850079 (UMLS CUI [4])
    Pathology Postoperative
    Item
    post-operative pathology will not exclude patients from this study
    boolean
    C0205469 (UMLS CUI [1,1])
    C0231287 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Life circumstances Compliance behavior Limited
    Item
    patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
    boolean
    C0680082 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    Minimally Invasive Surgical Procedures | Cytoreductive surgery | Ovarian Carcinoma | Fallopian Tube Neoplasms | Malignant tumor of peritoneum | Advanced phase
    Item
    patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (mis) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
    boolean
    C0282624 (UMLS CUI [1])
    C3850079 (UMLS CUI [2])
    C0029925 (UMLS CUI [3])
    C0015558 (UMLS CUI [4])
    C0153467 (UMLS CUI [5])
    C0205179 (UMLS CUI [6])
    Chemotherapy Regimen | Malignant Neoplasms Gynecologic | Geriatric Assessment
    Item
    patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
    boolean
    C0392920 (UMLS CUI [1])
    C0006826 (UMLS CUI [2,1])
    C0205480 (UMLS CUI [2,2])
    C0017463 (UMLS CUI [3])
    Uterine Cancer Preoperative | Endometrial biopsy
    Item
    patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy
    boolean
    C0153567 (UMLS CUI [1,1])
    C0445204 (UMLS CUI [1,2])
    C1510477 (UMLS CUI [2])
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