ID

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Description

AMC-061 Enrollment Form (ENR) 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

Keywords

  1. 8/26/12 8/26/12 -
  2. 7/8/15 7/8/15 -
  3. 7/8/15 7/8/15 -
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August 26, 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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Brain and Central Nervous System Tumors NCT00890747 Registration - AMC-061 Enrollment Form (ENR) - 2913694v1.0

No Instruction available.

  1. StudyEvent: AMC-061 Enrollment Form (ENR)
    1. No Instruction available.
Unnamed1
Description

Unnamed1

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

TreatmentProjectedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Inclusion/exclusion Criteria
Description

Inclusion/exclusion Criteria

Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria061Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C19707
UMLS 2011AA ObjectClass
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25532
UMLS 2011AA Property
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Description

Exclusion Criteria

Exclusion Criteria
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria061Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C19707
UMLS 2011AA ObjectClass
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Description

Exclusion Criteria

Type of Cancer
Description

CancerSiteType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
HAART regimen type
Description

PatientHighlyActiveAntiretroviralTherapyRegimenType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16165
UMLS 2011AA Property
C0887947
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Karnofsky Performance Status (must be > 60%)
Description

KarnofskyPerformanceStatusScore

Data type

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Age (in years)
Description

PatientAgeYearCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Date Informed Consent Signed (mm/dd/yyyy)
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
Description

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
Description

SpecimenRelatedGeneticResearchConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C17938
UMLS 2011AA Property
C0314603
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
Description

BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Comments
Description

Comments

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411

Similar models

No Instruction available.

  1. StudyEvent: AMC-061 Enrollment Form (ENR)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment (mm/dd/yyyy)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
Item Group
Inclusion/exclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Inclusion Criteria
CL Item
Date Informed Consent Obtained (Date informed consent obtained)
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)
CL Item
Does The Participant Have A Cd4 Count > 50 Cells/ul (Does the participant have a CD4 count > 50 cells/uL)
CL Item
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 >= 8.0 gm/dL Absolute neutrophil count (ANC) >= 1500 cells/mm^3 Platelet count >= 100,000 /mm^3)
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))
CL Item
Total Bilirubin <= 1.5 Times Uln (upper Limit Of Normal) (if "no") Is The Elevated Bilirubin Felt To Be Secondary To Indinavir Therapy (if "yes") Is Total Bilirubin < 3.5 Mg/dl And Is Direct Bilirubin <= 1.5 Times Uln (Total bilirubin <= 1.5 times ULN (upper limit of normal) (If "No") Is the elevated bilirubin felt to be secondary to Indinavir therapy (If "Yes") Is total bilirubin < 3.5 mg/dL and is direct bilirubin <= 1.5 times ULN)
CL Item
(if "no) Is The Elevated Bilirubin Felt To Be Secondary To Atazanavir Therapy (if "yes") Is Direct Bilirubin <= 1.5 Times Uln Ast (sgot) And Alt (sgpt) <= 2.5 Times The Uln ((If "No) Is the elevated bilirubin felt to be secondary to Atazanavir therapy (If "Yes") Is direct bilirubin <= 1.5 times ULN AST (SGOT) and ALT (SGPT) <= 2.5 times the ULN)
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)
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)
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)
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)
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)
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)
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)
CL Item
Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)
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)
CL Item
Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
CL Item
Participant's Age (in Years) (Participant's age (in years))
Item Group
Exclusion Criteria
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Exclusion Criteria
CL Item
Does The Participant Have A Concurrent Active Opportunistic Infection (Does the participant have a concurrent active opportunistic infection)
CL Item
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) >= 3 beats in a row))
CL Item
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 >= 2)
CL Item
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 >=100 mmHg despite optimal medical therapy) or unstable angina)
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)
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)
CL Item
Does The Participant Have A Qtc Interval > 500 Msec (Does the participant have a QTc interval > 500 msec)
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)
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)
CL Item
Does The Participant Have Serious Cardiac Arrhythmia Requiring Medication (Does the participant have serious cardiac arrhythmia requiring medication)
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)
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)
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)
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)
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.))
CL Item
If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
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)
Item Group
Exclusion Criteria
Item
Type of Cancer
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
Code List
Type of Cancer
CL Item
Non-hodgkin's Lymphoma (Non-Hodgkin's lymphoma)
C3211 (NCI Thesaurus)
C0024305 (UMLS 2011AA)
CL Item
Kaposi Sarcoma (KS)
C9087 (NCI Thesaurus)
C0036220 (UMLS 2011AA)
CL Item
Renal Cell Carcinoma (Renal Cell Cancer)
C9385 (NCI Thesaurus)
C0007134 (UMLS 2011AA)
CL Item
Solid Neoplasm (Solid tumor)
C9292 (NCI Thesaurus)
C0280100 (UMLS 2011AA)
CL Item
Hematologic Malignancy (Hematologic malignancy)
Item
HAART regimen type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16165 (NCI Thesaurus Property)
C0887947 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
Code List
HAART regimen type
CL Item
Nnrti-based Only (NNRTI-based only)
CL Item
Non-ritonavir Pi-based Only (Non-ritonavir PI-based only)
CL Item
Ritonavir Pi-based Only (Ritonavir PI-based only)
CL Item
Nnrti- And Non-ritonavir Pi-based (NNRTI- and non-ritonavir PI-based)
CL Item
Nnrti- And Ritonavir Pi-based (NNRTI- and ritonavir PI-based)
CL Item
Neither Pi Nor Nnrti Based (Neither PI nor NNRTI based)
KarnofskyPerformanceStatusScore
Item
Karnofsky Performance Status (must be > 60%)
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
PatientAgeYearCount
Item
Age (in years)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item Group
Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
Item
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
text
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C17938 (NCI Thesaurus Property)
C0314603 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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