ID

1084

Beschrijving

ACOSOG-Z1072 Registration Worksheet Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6EC42FC0-2010-95F5-E040-BB89AD432658

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6EC42FC0-2010-95F5-E040-BB89AD432658

Trefwoorden

Breast Neoplasms

Geüploaded op

26 augustus 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00723294 Registration - ACOSOG-Z1072 Registration Worksheet - 2919301v1.0

model
Details

Instructions: Mark the appropriate line for each Inclusion and Exclusion Criterion below. Each criterion must be answered and all protocol criteria must be met prior to registering the patient into this study. (If any items are marked "N/A" [not applicable], patient is still eligible to be registered into the study.) NOTE: Each criterion must be addressed and documented in the patient's medical record.)

1 Formulieren

StudyEvent: ACOSOG-Z1072 Registration Worksheet
1. Instructions: Mark the appropriate line for each Inclusion and Exclusion Criterion below. Each criterion must be answered and all protocol criteria must be met prior to registering the patient into this study. (If any items are marked "N/A" [not applicable], patient is still eligible to be registered into the study.) NOTE: Each criterion must be addressed and documented in the patient's medical record.)

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header Module

Item Group

Header Module

ProtocolACOSOGIdentifierNumber

Item

Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19712 (NCI Thesaurus Property)
C1515944 (UMLS 2011AA Property)

PatientCoordinatingIdentifierNumber

Item

Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientInitialsName

Item

Patient Initials (L F M)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

InstitutionIdentifierNumber

Item

Institution Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

InstitutionName

Item

Institution

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended (if data are amended, please circle in red when using paper form)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended (if data are amended, please circle in red when using paper form)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Eligibility Criteria

Item Group

Eligibility Criteria

InvasiveBreastCarcinomaHistologicallyConfirmedIndicator

Item

Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy (NOTE: Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. NOTE: Results of ER, PR, HER-2/neu and Oncotye DX if needed must be obtained on pre-registration needle core biopsy material. See Testing Guidelines Section 3.1)

text

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass)
C0205281 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.2

Code List

CL Item

Not Applicable (NA)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastBiopsyIndicator

Item

No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)

CL.3

Code List

No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer

CL Item

Not Applicable (NA)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastCarcinomaTwoCentimeterPresentIndicator

Item

Tumor size <= 2.0 cm in greatest diameter (Specifically, the tumor must measure <=2.0 cm in the axis parallel to the treatment probe and <=1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility)

text

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C49668 (NCI Thesaurus Property)
C0475210 (UMLS 2011AA Property)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.4

Code List

CL Item

Not Applicable (NA)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

MeasurableDiseaseEnhancingLesionPresentIndicator

Item

Tumor enhancement on pre-study MRI

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass)
C1513040 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C28746 (NCI Thesaurus Property)
C1333400 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.5

Code List

Tumor enhancement on pre-study MRI

CL Item

Not Applicable (NA)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TumorHistologicVariationIndicator

Item

Tumor with < 25% intraductal components in the aggregate

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25713 (NCI Thesaurus Property)
C0205419 (UMLS 2011AA Property)

CL.6

Code List

Tumor with < 25% intraductal components in the aggregate

CL Item

Not Applicable (NA)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator

Item

No prior or planned neoadjuvant chemotherapy for breast cancer

text

C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C9245 (NCI Thesaurus Property)
C0853879 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.7

Code List

No prior or planned neoadjuvant chemotherapy for breast cancer

CL Item

Not Applicable (NA)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientNegativePregnancyTestIndicator

Item

Non-pregnant and non-lactating (Patients of childbearing potential must have a negative serum or urine pregnancy test. Note: Peri-menopausal women must be mernorrheic for >12 months to be considered not of childbearing potential)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)

CL.8

Code List

CL Item

N/a (N/A)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastSizeDocumentedIndicator

Item

Adequate breast size for safe cryoablation (Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property)
C1301725 (UMLS 2011AA Property)

CL.9

Code List

CL Item

Not Applicable (NA)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Specimen Banking Consent

Item Group

Instructions

PatientOptionalConsentInd-2

Item

Patient consented to optional blood sample collection

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)

CL.10

Code List

Patient consented to optional blood sample collection

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Item

Patient's Initial Consent given for blood specimen use for research on the patient's cancer?

text

C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.11

Code List

Patient's Initial Consent given for blood specimen use for research on the patient's cancer?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Item

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

text

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)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.12

Code List

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Item

Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.13

Code List

Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TissueSpecimenResearchConsentUnrelatedInd-3

Item

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

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain)
C0445356 (UMLS 2011AA ValueDomain)

CL.14

Code List

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientContactConsentInd-3

Item

Patient consented to allow an ACOSOG representative to contact patient in the future to take part in more research

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C16452 (NCI Thesaurus Property)
C0009452 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.15

Code List

Patient consented to allow an ACOSOG representative to contact patient in the future to take part in more research

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Description of Primary Disease

Item Group

Description Of Primary Disease

MedDRACode

Item

MedDRA Code (10006285 [Breast cancer, NOS])

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

MalignantNeoplasmPrimarySiteText

Item

Primary Site (Tumor Breast)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)

BreastTumorHistologicCategory

Item

Histologic Type (check one)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.16

Code List

Histologic Type (check one)

CL Item

Infiltrating Ductal Carcinoma (Infiltrating ductal)

CL Item

Other Specify (Other)

TumorHistologicCategorySpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

BreastNeoplasmNuclearGradeCategory

Item

Nuclear Grade (check one)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C13361 (NCI Thesaurus Property)
C0521447 (UMLS 2011AA Property)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)

CL.17

Code List

Nuclear Grade (check one)

CL Item

Low (Low)

CL124342 (NCI Metathesaurus)

CL Item

Intermediate (Intermediate)

C0205103 (NCI Metathesaurus)

CL Item

High (High)

C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)

Biopsy Data

Item Group

Biopsy Data

SurgicalProcedureCoreBiopsyPerformedDate

Item

Date of core needle biopsy (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)

BiopsyNeedleBiopsyGaugePerformedValue

Item

Needle gauge

double

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15190 (NCI Thesaurus Property)
C0936232 (UMLS 2011AA Property)
C73120 (NCI Thesaurus Property)
C0456564 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

BiopsyMammotomeClipPlacementPerformedInd-2

Item

Biopsy clip placed at time of biopsy (check one)

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C47950 (NCI Thesaurus Property)
C1708928 (UMLS 2011AA Property)
C41148 (NCI Thesaurus Property)
C1524072 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.18

Code List

Biopsy clip placed at time of biopsy (check one)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BiopsyMammotomeClipPlacementPerformedName

Item

Name of biopsy clip

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C47950 (NCI Thesaurus Property)
C1708928 (UMLS 2011AA Property)
C41148 (NCI Thesaurus Property)
C1524072 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

InvasiveBreastCarcinomaHistologicallyConfirmedCellPercentageValue

Item

% Intraductal component (DCIS %)

double

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass)
C0205281 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Item

HER2 results/IHC (check one)

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass)
C0010802 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C61381 (NCI Thesaurus Property)
C0312586 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.19

Code List

HER2 results/IHC (check one)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

CL Item

Not Done: C49484 (not done)

C49484 (NCI Thesaurus)
C1272696 (UMLS 2011AA)

FISHCytologyResultType

Item

HER2 results/FISH (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.20

Code List

HER2 results/FISH (check one)

CL Item

Amplified (Amplified)

CL Item

Not Amplified (Not amplified)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

LaboratoryProcedureEvaluationPerformedDate

Item

Date (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureEvaluationPerformedDate

Item

Date (mm/dd/yyyy)

date

Estrogen/Progesterone Data

Item Group

Estrogen/progesterone Data

ERLevelTumorStatus

Item

ER Status (check one)

text

C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)

CL.21

Code List

ER Status (check one)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PgRStatusType

Item

PgR Status (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

CL.22

Code List

PgR Status (check one)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PregnancyTestPerformedInd-2

Item

Pregnancy test done (check one)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CL.23

Code List

Pregnancy test done (check one)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PregnancyLaboratoryProcedureNotPerformedReason

Item

Reason pregnancy test not performed (If no check one)

text

C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.24

Code List

Reason pregnancy test not performed (If no check one)

CL Item

Patient Is Female But Is Not Of Childbearing Potential (Patient is female but is not of childbearing potential)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PregnancyLaboratoryProcedureNotPerformedSpecify

Item

Other, specify

text

C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

LastMenstrualCycleOnsetDate

Item

Date of Onset of Most Recent Menstrual Period (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C0025329 (NCI Metathesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)

LaboratoryProcedureEvaluationPerformedDate

Item

Date (mm/dd/yyyy)

date

LaboratoryProcedureEvaluationPerformedDate

Item

Date (mm/dd/yyyy)

date

DataUnknownText

Item

Not Applicable (Patient is post-menopausal)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

Ultrasound/Mammogram

Item Group

Ultrasound/mammogram

LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2

Item

Is oncotype analysis planned (check one)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property)
C1709318 (UMLS 2011AA Property)

CL.25

Code List

Is oncotype analysis planned (check one)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TumorTotalVolumeStatus

Item

Is adequate tumor volume present (If yes check one)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25335 (NCI Thesaurus Property)
C0449468 (UMLS 2011AA Property)

CL.26

Code List

Is adequate tumor volume present (If yes check one)

CL Item

Cannot Undergo Cryoablation (Cannot undergo cryoablation)

CL Item

Need Additional Cores (Need additional cores)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DiagnosticImagingUltrasoundImagingPerformedDate

Item

Date of Ultrasound (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17230 (NCI Thesaurus Property)
C0041618 (UMLS 2011AA Property)

TumorSecondDimensionMeasurement

Item

Dimension 2 (Tumor size width cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)

TumorSecondDimensionMeasurement

Item

Dimension 2 (Tumor size width cm)

double

TumorThirdDimensionMeasurement

Item

Dimension 3 (Tumor size depth cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25260 (NCI Thesaurus Property)
C0205437 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)

TumorThirdDimensionMeasurement

Item

Dimension 3 (Tumor size depth cm)

double

MammogramPerformedDate

Item

Date of mammogram (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

TumorLargestDimensionMeasurement

Item

Dimension 1 (Tumor size length cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)

TumorLargestDimensionMeasurement

Item

Dimension 1 (Tumor size length cm)

double

BreastMalignantNeoplasmMammogramMicrocalcificationStatus

Item

Calcifications (check one)

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20178 (NCI Thesaurus Property)
C0024671 (UMLS 2011AA Property)
C8433 (NCI Thesaurus Property)
C0520594 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.27

Code List

Calcifications (check one)

CL Item

Absent (Absent)

C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)

CL Item

Present (Present)

C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)

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Breast Cancer NCT00723294 Registration - ACOSOG-Z1072 Registration Worksheet - 2919301v1.0

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