ID

11627

Beschreibung

AMC-061 Enrollment Form (ENR) NCT00890747 Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 08.07.15 08.07.15 -
  3. 08.07.15 08.07.15 -
Hochgeladen am

8. Juli 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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    AMC-061 Enrollment Form (ENR) NCT00890747

    Englisch

    No Instruction available.

    1 Formulare  
    1. StudyEvent: AMC-061 Enrollment Form (ENR)
      1. No Instruction available.
    Header Module
    Beschreibung

    Header Module

    Projected Start Date of Treatment (mm/dd/yyyy)
    Beschreibung

    Projected Start Date of Treatment (mm/dd/yyyy)

    Datentyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-1
    C3173309
    UMLS CUI-2
    C0016538
    Inclusion/exclusion Criteria
    Beschreibung

    Inclusion/exclusion Criteria

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ObjectClass-2
    C19707
    NCI Thesaurus Property
    C16112
    NCI Thesaurus Property-2
    C25532
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1515830
    UMLS CUI-2
    C1516637
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Type of Cancer
    Beschreibung

    Type of Cancer

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus Property
    C25341
    NCI Thesaurus ObjectClass
    C9305
    UMLS CUI-1
    C0872066
    Patient HAART regimen type?
    Beschreibung

    Patient HAART regimen type?

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16165
    NCI Thesaurus Property-2
    C15697
    UMLS CUI-1
    C0887947
    UMLS CUI-2
    C0040808
    Karnofsky Performance Status (must be > 60%)
    Beschreibung

    Karnofsky Performance Status (must be > 60%)

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C20641
    NCI Thesaurus ValueDomain
    C25338
    UMLS CUI-1
    C0206065
    %
    Age (in years)
    Beschreibung

    Age (in years)

    Datentyp

    integer

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain
    C29848
    NCI Thesaurus ValueDomain-2
    C25463
    NCI Thesaurus Property
    C25150
    UMLS CUI-1
    C2348575
    Date Informed Consent Signed (mm/dd/yyyy)
    Beschreibung

    Date Informed Consent Signed (mm/dd/yyyy)

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    NCI Thesaurus Property
    C25679
    UMLS CUI-1
    C0011008
    UMLS CUI-2
    C0514044
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ObjectClass-2
    C19707
    NCI Thesaurus Property
    C16112
    NCI Thesaurus Property-2
    C25370
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1515830
    UMLS CUI-2
    C1516637
    UMLS CUI-3
    C0680251
    Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
    Beschreibung

    Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens

    Does the participant agree to participate in the pharmacogenetics study associated with this protocol
    Beschreibung

    Does the participant agree to participate in the pharmacogenetics study associated with this protocol

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C19157
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    NCI Thesaurus Property-3
    C17938
    NCI Thesaurus Property-4
    C25460
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0586888
    UMLS CUI-2
    C0243064
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    Beschreibung

    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    NCI Thesaurus ObjectClass-2
    C12434
    NCI Thesaurus ObjectClass-3
    C19157
    NCI Thesaurus Property
    C17649
    NCI Thesaurus Property-2
    C15319
    NCI Thesaurus Property-3
    C67527
    NCI Thesaurus Property-4
    C2991
    NCI Thesaurus Property-5
    C25460
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0040300
    UMLS CUI-2
    C0229664
    UMLS CUI-3
    C0370003
    UMLS CUI-4
    C1515836
    Comments
    Beschreibung

    Comments

    Comments
    Beschreibung

    Comments

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS CUI-1
    C0282411
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    Ähnliche Modelle

    No Instruction available.

    1 Formulare
    1. StudyEvent: AMC-061 Enrollment Form (ENR)
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header Module
    Projected Begin Date
    Item
    Projected Start Date of Treatment (mm/dd/yyyy)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    C3173309 (UMLS CUI-1)
    C0016538 (UMLS CUI-2)
    Item Group
    Inclusion/exclusion Criteria
    Item
    Inclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C19707 (NCI Thesaurus ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C25532 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C1515830 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    CL.1
    Code List
    Inclusion Criteria
    CL Item
    Date Informed Consent Obtained (Date informed consent obtained)
    C0514044 (UMLS CUI-1)
    CL Item
    Does The Participant Agree To Employ An Effective Barrier Method Of Birth Control Throughout The Study And For Up To 3 Months Following Discontinuation Of Study Drug (Does the participant agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug)
    C0700589 (UMLS CUI-1)
    CL Item
    Does The Participant Have A Cd4 Count > 50 Cells/ul (Does the participant have a CD4 count > 50 cells/uL)
    C3541261 (UMLS CUI-1)
    CL Item
    Creatinine Within Institutional Normal Limits Or Glomerular Filtration Rate (gfr) > 60 Ml/min/m^2 (calculated By The Cockcroft-gault Equation) (Creatinine within institutional normal limits or Glomerular filtration rate (GFR) > 60 mL/min/m^2 (calculated by the Cockcroft-Gault equation))
    C0428279 (UMLS CUI-1)
    CL Item
    Does The Participant Have A Histologically Or Cytologically Confirmed Nhl, Biopsy-proven Ks Or Solid Tumor Or Hematological Malignancy (Does the participant have a histologically or cytologically confirmed NHL, biopsy-proven KS or solid tumor or hematological malignancy)
    C0024305 (UMLS CUI-1)
    C0036220 (UMLS CUI-2)
    C0280100 (UMLS CUI-3)
    C0376545 (UMLS CUI-4)
    CL Item
    Does The Participant Have Serologic Documentation Of Hiv Infection At Any Time Prior To Study Entry, As Evidenced By Positive Elisa, Positive Western Blot, Or Other Federally Approved Licensed Hiv Test (Does the participant have serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test)
    C0019693 (UMLS CUI-1)
    CL Item
    Does The Participant Have The Ability And Willingness To Give Written Informed Consent (Does the participant have the ability and willingness to give written informed consent)
    C0811741 (UMLS CUI-1)
    CL Item
    If The Participant Is Female, And Of Child-bearing Potential, Has She Had A Negative Pregnancy Test Within 72 Hours Before Initiation Of Study Drug Dosing (If the participant is female, and of child-bearing potential, has she had a negative pregnancy test within 72 hours before initiation of study drug dosing)
    C1960468 (UMLS CUI-1)
    C0427780 (UMLS CUI-2)
    CL Item
    If Yes, Indicate Cancer Type (see Protocol Section 4.0 For Specific Eligibility Criteria) Nhl, Ks, Renal Cell Cancer, Solid Tumor, Hematologic Malignancy (If Yes, indicate cancer type (see protocol section 4.0 for specific eligibility criteria) NHL, KS, Renal Cell Cancer, Solid tumor, Hematologic malignancy)
    C0872066 (UMLS CUI-1)
    CL Item
    Is The Participant On Stable Anti-retroviral Therapy For At Least 4 Weeks With A Pi-based Or Nnrti-based Regimen Of At Least Three Drugs, With No Intention To Change The Regimen Within 8 Weeks After Starting Study Drug (Is the participant on stable anti-retroviral therapy for at least 4 weeks with a PI-based or NNRTI-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks after starting study drug)
    C0887947 (UMLS CUI-1)
    CL Item
    If Yes, Indicate Haart Regimen Type Nnrti-based Only, Non Ritonavir Pi-based Only, Ritonavir Pi-based Only, Nnrti- And Non Ritonavir Pi-based, Nnrti- And Ritonavir Pi-based, Neither Pi Nor Nnrti Based (If Yes, indicate HAART regimen type NNRTI-based only, Non ritonavir PI-based only, Ritonavir PI-based only, NNRTI- and non ritonavir PI-based, NNRTI- and ritonavir PI-based, Neither PI nor NNRTI based)
    C0887947 (UMLS CUI-1)
    CL Item
    Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)
    C3845481 (UMLS CUI-1)
    CL Item
    Is The Participant, In The Opinion Of The Investigator, Capable Of Complying With This Protocol (Is the participant, in the opinion of the Investigator, capable of complying with this protocol)
    C0582783 (UMLS CUI-1)
    CL Item
    Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
    C0206065 (UMLS CUI-1)
    CL Item
    Participant's Age (in Years) (Participant's age (in years))
    C0681850 (UMLS CUI-1)
    C0001779 (UMLS CUI-2)
    CL Item
    8.0 gm/dL Absolute neutrophil count (ANC) >= 1500 cells/mm^3 Platelet count >= 100,000 /mm^3=Does The Participant Have The Following Laboratory Parameters Within 7 Days Prior To Study Entry Hemoglobin >= 8.0 Gm/dl Absolute Neutrophil Count (anc) >= 1500 Cells/mm^3 Platelet Count >= 100,000 /mm^3 (Does the participant have the following laboratory parameters within 7 days prior to study entry Hemoglobin >)
    C0948762 (UMLS CUI-1)
    CL Item
    1.5 times ULN (upper limit of normal) (If  (Total bilirubin <)
    C0368753 (UMLS CUI-1)
    CL Item
    1.5 times ULN AST (SGOT) and ALT (SGPT) <= 2.5 times the ULN=(if ((If )
    C0004002 (UMLS CUI-1)
    C0001899 (UMLS CUI-2)
    Item Group
    Exclusion Criteria
    Item
    Type of Cancer
    text
    C25284 (NCI Thesaurus ValueDomain)
    C25341 (NCI Thesaurus Property)
    C9305 (NCI Thesaurus ObjectClass)
    C0872066 (UMLS CUI-1)
    CL.3
    Code List
    Type of Cancer
    CL Item
    Non-hodgkin's Lymphoma (Non-Hodgkin's lymphoma)
    C3211 (NCI Thesaurus)
    C0024305 (UMLS CUI-1)
    CL Item
    Kaposi Sarcoma (KS)
    C9087 (NCI Thesaurus)
    C0036220 (UMLS CUI-1)
    CL Item
    Renal Cell Carcinoma (Renal Cell Cancer)
    C9385 (NCI Thesaurus)
    C0007134 (UMLS CUI-1)
    CL Item
    Solid Neoplasm (Solid tumor)
    C9292 (NCI Thesaurus)
    C0280100 (UMLS CUI-1)
    CL Item
    Hematologic Malignancy (Hematologic malignancy)
    C0376545 (UMLS CUI-1)
    Item
    Patient HAART regimen type?
    text
    C25284 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C16165 (NCI Thesaurus Property)
    C15697 (NCI Thesaurus Property-2)
    C0887947 (UMLS CUI-1)
    C0040808 (UMLS CUI-2)
    CL.4
    Code List
    Patient HAART regimen type?
    CL Item
    Nnrti-based Only (NNRTI-based only)
    C3541376 (UMLS CUI-1)
    CL Item
    Non-ritonavir Pi-based Only (Non-ritonavir PI-based only)
    C0033607 (UMLS CUI-1)
    C0292818 (UMLS CUI-2)
    C1518422 (UMLS CUI-3)
    CL Item
    Ritonavir Pi-based Only (Ritonavir PI-based only)
    C3541376 (UMLS CUI-1)
    C3541376 (UMLS CUI-2)
    CL Item
    Nnrti- And Non-ritonavir Pi-based (NNRTI- and non-ritonavir PI-based)
    C3541376 (UMLS CUI-1)
    C3541376 (UMLS CUI-2)
    C3541376 (UMLS CUI-3)
    CL Item
    Nnrti- And Ritonavir Pi-based (NNRTI- and ritonavir PI-based)
    C3541376 (UMLS CUI-1)
    C3541376 (UMLS CUI-2)
    CL Item
    Neither Pi Nor Nnrti Based (Neither PI nor NNRTI based)
    C3541376 (UMLS CUI-1)
    C3541376 (UMLS CUI-2)
    C3843060 (UMLS CUI-3)
    KarnofskyPerformanceStatusScore
    Item
    Karnofsky Performance Status (must be > 60%)
    float
    C25367 (NCI Thesaurus Property)
    C20641 (NCI Thesaurus ObjectClass)
    C25338 (NCI Thesaurus ValueDomain)
    C0206065 (UMLS CUI-1)
    PatientAgeYearCount
    Item
    Age (in years)
    integer
    C16960 (NCI Thesaurus ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C25150 (NCI Thesaurus Property)
    C2348575 (UMLS CUI-1)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16468 (NCI Thesaurus ObjectClass)
    C25679 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-1)
    C0514044 (UMLS CUI-2)
    Item
    Exclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C19707 (NCI Thesaurus ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C25370 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C1515830 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    C0680251 (UMLS CUI-3)
    CL.2
    Code List
    Exclusion Criteria
    CL Item
    Does The Participant Have A Concurrent Active Opportunistic Infection (Does the participant have a concurrent active opportunistic infection)
    C0029118 (UMLS CUI-1)
    CL Item
    Does The Participant Have A Pre-existing Thyroid Abnormality That Cannot Be Maintained With Medication To Keep Measures Of Thyroid Stimulating Hormone Within The Normal Range (Does the participant have a pre-existing thyroid abnormality that cannot be maintained with medication to keep measures of thyroid stimulating hormone within the normal range)
    C0040128 (UMLS CUI-1)
    CL Item
    Does The Participant Have A Psychiatric Illness That Would Limit Compliance With Study Requirements (Does the participant have a psychiatric illness that would limit compliance with study requirements)
    C0004936 (UMLS CUI-1)
    CL Item
    Does The Participant Have A Qtc Interval > 500 Msec (Does the participant have a QTc interval > 500 msec)
    C1560305 (UMLS CUI-1)
    CL Item
    Does The Participant Have Another Severe And/or Life-threatening Medical Disease (Does the participant have another severe and/or life-threatening medical disease)
    C0973444 (UMLS CUI-1)
    C3846017 (UMLS CUI-2)
    CL Item
    Does The Participant Have Gastrointestinal Tract Disease Resulting In An Inability To Take Oral Medication Or A Requirement For Iv Alimentation, Prior Surgical Procedures Affecting Absorption, Or Active Peptic Ulcer Disease (Does the participant have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
    C0017178 (UMLS CUI-1)
    CL Item
    Does The Participant Have Serious Cardiac Arrhythmia Requiring Medication (Does the participant have serious cardiac arrhythmia requiring medication)
    C0003811 (UMLS CUI-1)
    CL Item
    Has The Participant Had A Myocardial Infarction, Severe/unstable Angina, Coronary Artery Bypass Graft, Cerebrovascular Accident, Transient Ischemic Attack, Or Pulmonary Embolism Within 6 Months Of Study Entry (Has the participant had a myocardial infarction, severe/unstable angina, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of study entry)
    C0027051 (UMLS CUI-1)
    CL Item
    Does The Participant Have An Abnormal Left Ventricular Ejection Fraction Per Institutional Standards (Does the participant have an abnormal Left Ventricular Ejection Fraction per institutional standards)
    C1096403 (UMLS CUI-1)
    CL Item
    Has The Participant Had Acute Treatment For An Infection Or Other Serious Medical Illness Within 14 Days Prior To Study Entry (Has the participant had acute treatment for an infection or other serious medical illness within 14 days prior to study entry)
    C0517783 (UMLS CUI-1)
    CL Item
    Has The Participant Had Major Surgery Or Radiation Within 3 Weeks Prior To Study Entry (Has the participant had major surgery or radiation within 3 weeks prior to study entry)
    C3698433 (UMLS CUI-1)
    C0455620 (UMLS CUI-2)
    CL Item
    Has The Participant Received Antineoplastic Therapy, Including Investigational Drug Or Standard Treatment, Within 2 Weeks Of Study Entry? (must Be Able To Demonstrate Adequate Recovery From Prior Therapy-related Toxicities.) (Has the participant received antineoplastic therapy, including investigational drug or standard treatment, within 2 weeks of study entry? (Must be able to demonstrate adequate recovery from prior therapy-related toxicities.))
    C0003392 (UMLS CUI-1)
    CL Item
    If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
    C3242212 (UMLS CUI-1)
    CL Item
    Will The Participant Undergo Concurrent Treatment With Medications, Other Than Antiretroviral Drugs Used To Treat Hiv Infection, That Are Known To Inhibit Or Induce Cyp3a4 (Will the participant undergo concurrent treatment with medications, other than antiretroviral drugs used to treat HIV infection, that are known to inhibit or induce CYP3A4)
    C3830625 (UMLS CUI-2)
    C3850041 (UMLS CUI-3)
    CL Item
    3 beats in a row)=Does The Participant Have A History Of Serious Ventricular Arrhythmia (ventricular Tachycardia (vt) Or Ventricular Fibrillation (vf) >= 3 Beats In A Row) (Does the participant have a history of serious ventricular arrhythmia (ventricular tachycardia (VT) or ventricular fibrillation (VF) >)
    C0085612 (UMLS CUI-1)
    CL Item
    2=Does The Participant Have Ongoing Ventricular Cardiac Dysrhythmias Of Nci Ctcae Grade >= 2 (Does the participant have ongoing ventricular cardiac dysrhythmias of NCI CTCAE grade >)
    C0003811 (UMLS CUI-1)
    C3887242 (UMLS CUI-2)
    CL Item
    100 mmHg despite optimal medical therapy) or unstable angina=Does The Participant Have Clinically Significant Cardiovascular Disease, Including Uncontrolled Hypertension (diastolic Blood Pressure >=100 Mmhg Despite Optimal Medical Therapy) Or Unstable Angina (Does the participant have clinically significant cardiovascular disease, including uncontrolled hypertension (diastolic blood pressure >)
    C0007222 (UMLS CUI-1)
    Item Group
    Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
    Genetic Research Consent
    Item
    Does the participant agree to participate in the pharmacogenetics study associated with this protocol
    boolean
    C19157 (NCI Thesaurus ObjectClass)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C17938 (NCI Thesaurus Property-3)
    C25460 (NCI Thesaurus Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C0586888 (UMLS CUI-1)
    C0243064 (UMLS CUI-2)
    Blood Tissue Future Research Consent
    Item
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C12434 (NCI Thesaurus ObjectClass-2)
    C19157 (NCI Thesaurus ObjectClass-3)
    C17649 (NCI Thesaurus Property)
    C15319 (NCI Thesaurus Property-2)
    C67527 (NCI Thesaurus Property-3)
    C2991 (NCI Thesaurus Property-4)
    C25460 (NCI Thesaurus Property-5)
    C38147 (NCI Thesaurus ValueDomain)
    C0040300 (UMLS CUI-1)
    C0229664 (UMLS CUI-2)
    C0370003 (UMLS CUI-3)
    C1515836 (UMLS CUI-4)
    Item Group
    Comments
    ResearchCommentsText
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS CUI-1)
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