ID

43135

Beschrijving

CALGB 10201 REGISTRATION WORKSHEET Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B228B8A4-E2DC-4D1A-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B228B8A4-E2DC-4D1A-E034-0003BA12F5E7

Trefwoorden

Versies (3)
  1. 18-12-14 18-12-14 - Martin Dugas
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 20-09-21 20-09-21 -
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20 september 2021

DOI

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Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00085124 Registration - CALGB 10201 REGISTRATION WORKSHEET - 2076520v3.0

Engels

A Phase III Study of Daunorubicin and Cytarabine +/- G3139 (Genasense) in Previously Untreated Patients with Acute Myeloid Leukemia

1 Formulieren  
Protocol Administration
Beschrijving

Protocol Administration

IRB Approval Date (M M DD YYYY)
Beschrijving

IRBApprovalDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Responsible Contact
Beschrijving

ContactPersonatInstitution

Datatype

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
Date Informed Consent Signed (M M DD YYYY)
Beschrijving

InformedConsentDateSigned

Datatype

text

Phone
Beschrijving

PhoneNumber

Datatype

float

Projected Treatment Start Date (M M DD YYYY)
Beschrijving

ProjectedTreatmentBeginDate

Datatype

date

FAX
Beschrijving

FaxNumber

Datatype

float

Patient Demographics/pre-treatment Characteristics
Beschrijving

Patient Demographics/pre-treatment Characteristics

Patient Initials (Last , First Middle)
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Social Security Number
Beschrijving

PatientSocialSecurityNumber

Datatype

float

Birth Date (M M DD YYYY)
Beschrijving

PatientBirthDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Patient Hospital No.
Beschrijving

PatientHospitalNumber

Datatype

text

Gender
Beschrijving

PatientGender

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Race (Mark all that apply)
Beschrijving

PatientRace

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Ethnicity (Mark one)
Beschrijving

PatientEthnicity

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Performance Status (ECOG/Zubrod scale)
Beschrijving

PerformanceStatus

Datatype

text

Height (cm)
Beschrijving

PatientHeight

Datatype

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Weight (kg)
Beschrijving

PatientWeight

Datatype

float

Body Surface Area (2 m)
Beschrijving

BodySurfaceArea

Datatype

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
Method of Payment (USA only)
Beschrijving

PatientPaymentType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Patient's Zip Code
Beschrijving

PatientAddress,PostalCode

Datatype

float

Country Of Residence (If not USA)
Beschrijving

PatientAddress,Country

Datatype

text

Certification Of Eligibility
Beschrijving

Certification Of Eligibility

Is the patient eligible? (Stratification Factors)
Beschrijving

PatientEligibilityInd

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Protocol Design
Beschrijving

Protocol Design

Type of AML
Beschrijving

TypeofAML

Datatype

text

Assigned Treatment Arm
Beschrijving

TreatmentArmNumber

Datatype

text

Initial Patient Consent For Specimen Use
Beschrijving

Initial Patient Consent For Specimen Use

Patient's Initial Consent given for Specimen use for research on the patient's cancer?
Beschrijving

PatientInitialConsent,Specimen,Patient'scancerresearchInd

Datatype

boolean

Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?
Beschrijving

PatientInitialConsent,Specimen,Researchunrelatedtopatient'scancerInd

Datatype

boolean

Patient's Initial Consent given for further contact regarding specimen?
Beschrijving

PatientInitialConsent,Specimen,ContactInd

Datatype

boolean

Registration Information
Beschrijving

Registration Information

Assigned Participating Group Patient ID
Beschrijving

PatientStudyID,ParticipatingGroup

Datatype

text

CALGB Patient ID
Beschrijving

CALGBPatientID

Datatype

text

Registration Date (MM DD YYYY)
Beschrijving

RegistrationDate

Datatype

text

Registrar's Signature
Beschrijving

SignatureofPersonCompletingThisForm

Datatype

text

Ccrr Module For Calgb 10201 Registration Worksheet
Beschrijving

Ccrr Module For Calgb 10201 Registration Worksheet

Main Member Institution
Beschrijving

Institution Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Affiliate/Treating Institution
Beschrijving

AffiliateName

Datatype

text

CALGB Patient ID
Beschrijving

CALGBPatientID

Datatype

text

Physician of Record
Beschrijving

Investigator Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
Participating Group Name
Beschrijving

ParticipatingGroupName

Datatype

text

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Similar models

A Phase III Study of Daunorubicin and Cytarabine +/- G3139 (Genasense) in Previously Untreated Patients with Acute Myeloid Leukemia

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Protocol Administration
IRBApprovalDate
Item
IRB Approval Date (M M DD YYYY)
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
ContactPersonatInstitution
Item
Responsible Contact
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
InformedConsentDateSigned
Item
Date Informed Consent Signed (M M DD YYYY)
text
PhoneNumber
Item
Phone
float
ProjectedTreatmentBeginDate
Item
Projected Treatment Start Date (M M DD YYYY)
date
FaxNumber
Item
FAX
float
Item Group
Patient Demographics/pre-treatment Characteristics
Patient Initials
Item
Patient Initials (Last , First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientSocialSecurityNumber
Item
Social Security Number
float
PatientBirthDate
Item
Birth Date (M M DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital No.
text
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.1
Code List
Gender
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
Item
Race (Mark all that apply)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.2
Code List
Race (Mark all that apply)
CL Item
American Indian or Alaskan Native (American Indian or Alaskan Native)
CL Item
Pacific_islander_cdus (Native Hawaiian or Other Pacific Islander)
CL Item
Asian_cdus (Asian)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Black_cdus (Black or African American)
CL Item
White_cdus (White)
Item
Ethnicity (Mark one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.3
Code List
Ethnicity (Mark one)
CL Item
Hispanic_or_latino (Hispanic or Latino)
CL Item
Non_hispanic (Non-Hispanic)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PerformanceStatus
Item
Performance Status (ECOG/Zubrod scale)
text
PatientHeight
Item
Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeight
Item
Weight (kg)
float
BodySurfaceArea
Item
Body Surface Area (2 m)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
Item
Method of Payment (USA only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL.4
Code List
Method of Payment (USA only)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Self Pay (no Insurance) (Self Pay)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Military Sponsored (including Champus & Tricare) (Military)
CL Item
Private Insurance (Private Insurance)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
No Means Of Payment (no Insurance) (No means of payment)
CL Item
Military Or Veterans Sponsored Nos (Veterans Administration Sponsored)
PatientAddress,PostalCode
Item
Patient's Zip Code
float
PatientAddress,Country
Item
Country Of Residence (If not USA)
text
Item Group
Certification Of Eligibility
PatientEligibilityInd
Item
Is the patient eligible? (Stratification Factors)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Item Group
Protocol Design
Item
Type of AML
text
CL.6
Code List
Type of AML
CL Item
De Novo Aml (de novo AML)
CL Item
Aml With Antecedent Mds (AML with antecedent MDS)
Item
Assigned Treatment Arm
text
CL.7
Code List
Assigned Treatment Arm
CL Item
G3139 and Cytarabine and Daunorubicin (G3139 and Cytarabine and Daunorubicin)
CL Item
Cytarabine and Daunorubicin (Cytarabine and Daunorubicin)
Item Group
Initial Patient Consent For Specimen Use
PatientInitialConsent,Specimen,Patient'scancerresearchInd
Item
Patient's Initial Consent given for Specimen use for research on the patient's cancer?
boolean
PatientInitialConsent,Specimen,Researchunrelatedtopatient'scancerInd
Item
Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?
boolean
PatientInitialConsent,Specimen,ContactInd
Item
Patient's Initial Consent given for further contact regarding specimen?
boolean
Item Group
Registration Information
PatientStudyID,ParticipatingGroup
Item
Assigned Participating Group Patient ID
text
CALGBPatientID
Item
CALGB Patient ID
text
RegistrationDate
Item
Registration Date (MM DD YYYY)
text
SignatureofPersonCompletingThisForm
Item
Registrar's Signature
text
Item Group
Ccrr Module For Calgb 10201 Registration Worksheet
Institution Name
Item
Main Member Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
AffiliateName
Item
Affiliate/Treating Institution
text
CALGBPatientID
Item
CALGB Patient ID
text
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
ParticipatingGroupName
Item
Participating Group Name
text
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