ID

2848

Beschrijving

CALGB-81003 OPEN Registration Worksheet (Phase II) Combination Chemotherapy With or Without Ganitumab in Treating Patients With Previously Untreated Metastatic Pancreatic Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0263E2E-A570-C223-E040-BB89AD4317AC

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0263E2E-A570-C223-E040-BB89AD4317AC

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

19 september 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT01473303 Registration - CALGB-81003 OPEN Registration Worksheet (Phase II) - 3297544v1.0

Engels

Phase IB / Randomized Phase II Study of Folfirinox plus AMG-479 or Placebo in Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

1 Formulieren  
Protocol Administration
Beschrijving

Protocol Administration

Date Informed Consent Signed (MM DD YYYY)
Beschrijving

InformedConsentFormSignedDate

Datatype

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
HIPAA Authorization Date (MM DD YYYY)
Beschrijving

PatientSignedDischargeMedicalRecordDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Projected Start Date of Treatment (MM DD YYYY)
Beschrijving

TreatmentProjectedBeginDate

Datatype

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
Pre-treatment Characteristics
Beschrijving

Pre-treatment Characteristics

ECOG Performance Status
Beschrijving

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Height (cm)
Beschrijving

PatientHeightMeasurement

Datatype

double

Maateenheden
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Weight (kg)
Beschrijving

PatientWeightMeasurement

Datatype

double

Maateenheden
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
Disease code (pancreas)
Beschrijving

MedicalDictionaryforRegulatoryActivitiesTerminologyIdentifierCode

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
NCI Thesaurus ValueDomain
C43820
UMLS 2011AA ValueDomain
C1140263
Certification Of Eligibility
Beschrijving

Certification Of Eligibility

In the opinion of the investigator, is the patient eligible (for CALGB 61103)
Beschrijving

PatientEligibilityIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Protocol Design
Beschrijving

Protocol Design

ECOG Performance Status
Beschrijving

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Prior Therapy
Beschrijving

Prior Therapy

Prior Cancer Therapies (If patient received prior cancer therapy: Mark an X for each therapy received. For chemotherapies, specify number of regimens received. The number of regimens refers to the number of treatment courses, not the number of cycles received for a course of treatment. For example, a patient who received 3 cycles while on Treatment A and 6 cycles while on Treatment B has received 2 treatment regimens - Treatment A and Treatment B.)
Beschrijving

PriorTherapyAdministeredType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Number of regimens (Chemotherapy multiple agents systemic)
Beschrijving

PriorMultipleAgentChemotherapyAdministeredCount

Datatype

double

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C17648
UMLS 2011AA ObjectClass
C0439064
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of regimens (Chemotherapy non-cytotoxic)
Beschrijving

PriorNon-cytotoxicAgentChemotherapyAdministeredCount

Datatype

double

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C83487
UMLS 2011AA ObjectClass
C2827065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of regimens (Chemotherapy - NOS)
Beschrijving

PriorChemotherapyRegimenNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Number of regimens (Chemotherapy single agent systemic)
Beschrijving

SingleAgentSystemicChemotherapyAdministeredCount

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C15756
UMLS 2011AA ObjectClass
C0854619
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Initial Patient Consent For Specimen Use
Beschrijving

Initial Patient Consent For Specimen Use

I choose to take part in the Patient-Reported Outcomes Study and agree to complete the questionnaire once per month (consent question #1 - must be Yes for participation in 71102)
Beschrijving

PatientAncillaryStudyOneEligibilityDeterminationInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C66832
UMLS 2011AA Property
C0205447
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C16041
UMLS 2011AA Property
C1515980
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
Beschrijving

PatientEligibilityIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Initial Patient Consent For Specimen Use
Beschrijving

Initial Patient Consent For Specimen Use

My coded samples and related coded information may be used to learn about, prevent, find or treat my type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #2 - must be Yes for participation in 151109 and 61103)
Beschrijving

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat any type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #3)
Beschrijving

SpecimenResearchConsentSharedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15319
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
Beschrijving

PatientEligibilityIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include research on inherited traits (genes passed on in families) (consent question #4)
Beschrijving

SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C25699
UMLS 2011AA ObjectClass
C1519429
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Someone from my hospital or CALGB may contact me in the future to ask me to take part in more research (consent question #5)
Beschrijving

PatientAdditionalResearchConsentInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25406
UMLS 2011AA Property
C1524062
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Certification Of Eligibility
Beschrijving

Certification Of Eligibility

In the opinion of the investigator, is the patient eligible (for CALGB 61103)
Beschrijving

PatientEligibilityIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
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Similar models

Phase IB / Randomized Phase II Study of Folfirinox plus AMG-479 or Placebo in Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Protocol Administration
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)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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
Pre-treatment Characteristics
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.4
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
PatientHeightMeasurement
Item
Height (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Weight (kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
Item
Disease code (pancreas)
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
C43820 (NCI Thesaurus ValueDomain)
C1140263 (UMLS 2011AA ValueDomain)
CL.2
Code List
Disease code (pancreas)
CL Item
Pancreas (10052747)
C12393 (NCI Thesaurus)
C0030274 (UMLS 2011AA)
Item Group
Certification Of Eligibility
Item
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.13
Code List
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Protocol Design
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.4
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
Item Group
Prior Therapy
Item
Prior Cancer Therapies (If patient received prior cancer therapy: Mark an X for each therapy received. For chemotherapies, specify number of regimens received. The number of regimens refers to the number of treatment courses, not the number of cycles received for a course of treatment. For example, a patient who received 3 cycles while on Treatment A and 6 cycles while on Treatment B has received 2 treatment regimens - Treatment A and Treatment B.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.5
Code List
Prior Cancer Therapies (If patient received prior cancer therapy: Mark an X for each therapy received. For chemotherapies, specify number of regimens received. The number of regimens refers to the number of treatment courses, not the number of cycles received for a course of treatment. For example, a patient who received 3 cycles while on Treatment A and 6 cycles while on Treatment B has received 2 treatment regimens - Treatment A and Treatment B.)
CL Item
No Previous Exposure To Drug (nos) (No prior therapy)
CL Item
Agents Administered To Control The Replication And/or Spread Of Viruses (Anti-retroviral therapy)
CL Item
Treatment With An Agent That Prevents Or Impairs The Translation Of The Genetic Message For Production Of A Specific Protein (Antisense)
CL Item
High Dose Chemotherapy Combined With Transplantation Of Bone Marrow Cells (Bone marrow transplant)
CL Item
Systemic Chemotherapy With A Regimen Containing Multiple Agents (Chemotherapy multiple agents systemic)
CL Item
Prior Therapy With Agents That Are Not Known To Cause Damage To Cycling Cells (Chemotherapy non-cytotoxic)
CL Item
Non-systemic Chemotherapy Treatment Or Chemotherapy Not Described By Chemotherapy Single Agent Systemic Or Multi-agent Systemic (Chemotherapy (NOS))
CL Item
Systemic Chemotherapy With A Single Agent Regimen (Chemotherapy single agent systemic)
CL Item
Treatment Of Human Disease By Gene Transfer (Gene transfer)
CL Item
Image Directed Local Therapy (Image Directed Local Therapy)
CL Item
Cancer Therapy Which Incorporates Hormonal Manipulation (Hormonal therapy)
CL Item
Drug And/or Immunotherapy (Drug and/or Immunotherapy)
CL Item
Anticancer Treatment With A Live, Replication-competent Virus (Oncolytic virotherapy)
CL Item
Targeted Ionizing Radiation Therapy Utilizing Radioactive Implants Or Seeds (Radiation therapy)
CL Item
Surgical Procedure, Or Operation, With Therapeutic Intent (Surgery)
CL Item
Therapy Nos (Therapy (NOS))
CL Item
Substance Or Group Of Substances Administered To Induce The Immune System To Recognize And Destroy Tumors Or Microorganisms (Vaccine)
CL Item
Hematopoietic Stem Cell Transplantation (Hematopoietic Stem Cell Transplantation)
PriorMultipleAgentChemotherapyAdministeredCount
Item
Number of regimens (Chemotherapy multiple agents systemic)
double
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C17648 (NCI Thesaurus ObjectClass)
C0439064 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PriorNon-cytotoxicAgentChemotherapyAdministeredCount
Item
Number of regimens (Chemotherapy non-cytotoxic)
double
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C83487 (NCI Thesaurus ObjectClass)
C2827065 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PriorChemotherapyRegimenNumber
Item
Number of regimens (Chemotherapy - NOS)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
SingleAgentSystemicChemotherapyAdministeredCount
Item
Number of regimens (Chemotherapy single agent systemic)
double
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15756 (NCI Thesaurus ObjectClass)
C0854619 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Initial Patient Consent For Specimen Use
Item
I choose to take part in the Patient-Reported Outcomes Study and agree to complete the questionnaire once per month (consent question #1 - must be Yes for participation in 71102)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C66832 (NCI Thesaurus Property)
C0205447 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16041 (NCI Thesaurus Property)
C1515980 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.6
Code List
I choose to take part in the Patient-Reported Outcomes Study and agree to complete the questionnaire once per month (consent question #1 - must be Yes for participation in 71102)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.13
Code List
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
My coded samples and related coded information may be used to learn about, prevent, find or treat my type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #2 - must be Yes for participation in 151109 and 61103)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
My coded samples and related coded information may be used to learn about, prevent, find or treat my type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #2 - must be Yes for participation in 151109 and 61103)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat any type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #3)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL.9
Code List
My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat any type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #3)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.13
Code List
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include research on inherited traits (genes passed on in families) (consent question #4)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.10
Code List
My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include research on inherited traits (genes passed on in families) (consent question #4)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Someone from my hospital or CALGB may contact me in the future to ask me to take part in more research (consent question #5)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.11
Code List
Someone from my hospital or CALGB may contact me in the future to ask me to take part in more research (consent question #5)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Certification Of Eligibility
Item
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.13
Code List
In the opinion of the investigator, is the patient eligible (for CALGB 61103)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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