INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Assessment Date
Item
Date of evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Data amended
Item
Amended Data
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
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)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Breast Conserving Therapy
Item
Was the patient's clinical breast exam normal?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C14165 (NCI Thesaurus Property-2)
C0205307 (UMLS 2011AA Property-2)
C70552 (NCI Thesaurus ObjectClass)
C2347781 (UMLS 2011AA ObjectClass)
Code List
Was the patient's clinical breast exam normal?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ClinicalBreastExaminationAbnormalEvaluationText
Item
Describe abnormality (If no,)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25401 (NCI Thesaurus Property-2)
C0205161 (UMLS 2011AA Property-2)
C70552 (NCI Thesaurus ObjectClass)
C2347781 (UMLS 2011AA ObjectClass)
BreastConservationTreatmentPriorNeoadjuvantTherapyQualificationInd-2
Item
Is the patient currently(before receiving neoadjuvant chemotherapy) a candidate for breast conserving treatment
boolean
C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property-2)
C43608 (NCI Thesaurus Property-3)
C1709790 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Reason not a candidate (If no,)
text
C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property-2)
CL052458 (NCI Metathesaurus Property)
C43608 (NCI Thesaurus Property-3)
C1709790 (UMLS 2011AA Property-3)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason not a candidate (If no,)
CL Item
Absolute Contraindication To Radiation Therapy (Absolute contraindication to radiation therapy)
CL Item
Diffuse Suspicious Microcalcifications (Diffuse suspicious microcalcifications)
CL Item
Multicentric Breast Cancer (Multicentric breast cancer)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Probable Poor Cosmetic Outcome (Probable poor cosmetic outcome)
CL Item
Breast Cancer Pt4 Tnm Finding (T4)
C48985 (NCI Thesaurus)
C1707033 (UMLS 2011AA)
CL Item
Tumor Is Too Large In Relation To Native Breast Size (Tumor is too large in relation to native breast size)
BreastConservationTreatmentPriorNeoadjuvantTherapyNotQualificationSpecify
Item
Other, specify
text
C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property-2)
CL052458 (NCI Metathesaurus Property)
C43608 (NCI Thesaurus Property-3)
C1709790 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Absolute contraindication to radiation therapy
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15280 (NCI Thesaurus ObjectClass-2)
C0917927 (UMLS 2011AA ObjectClass-2)
C50646 (NCI Thesaurus Property)
C1301624 (UMLS 2011AA Property)
Code List
Absolute contraindication to radiation therapy
CL Item
Connective Tissue Disorder (Connective Tissue Disorder)
C26729 (NCI Thesaurus)
C0009782 (UMLS 2011AA)
CL Item
Patient Access To Prescribed Radiation Therapy (Patient access to prescribed radiation therapy)
CL Item
Patient Compliance With Prescribed Radiation Therapy (Patient compliance with prescribed radiation therapy)
CL Item
Prior Radiation Therapy (Prior radiation therapy)
C15477 (NCI Thesaurus)
C0279134 (UMLS 2011AA)
BreastConservationTreatmentRadiationTherapyConnectiveTissueDisorderMedicalContraindicationSpecify
Item
Connective tissue disorder, specify
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15280 (NCI Thesaurus ObjectClass-2)
C0917927 (UMLS 2011AA ObjectClass-2)
C26729 (NCI Thesaurus Property)
C0009782 (UMLS 2011AA Property)
C50646 (NCI Thesaurus Property-2)
C1301624 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Axillary Node
AxillaryLymphNodePriorNeoadjuvantTherapyEvaluationInd-2
Item
Was the patient's pre-neoadjuvent chemotherapy treatment axillary nodal status evaluated?
boolean
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15665 (NCI Thesaurus Property-3)
C0600558 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Code List
Method of Evaluation
CL Item
Axillary Dissection (Axillary dissection)
CL Item
Excisional Biopsy Or Lumpectomy (Excisional biopsy or lumpectomy)
CL Item
Fine Needle Aspiration Biopsy (Fine needle aspiration biopsy)
CL Item
Mri Scan (MRI scan)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Pet Scan (PET scan)
CL Item
Sentinel Node Biopsy (Sentinel node biopsy)
Item
Clinical N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Clinical N Stage
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)
CL Item
Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed Or Matted, Or In Clinically Apparent* Ipsilateral Internal Mammary Nodes In The Absence Of Clinically Evident Lymph Node Metastasis (N2)
Item
Results
text
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C15665 (NCI Thesaurus Property-3)
C0600558 (UMLS 2011AA Property-3)
C20200 (NCI Thesaurus ValueDomain)
C1274040 (UMLS 2011AA ValueDomain)
Code List
Results
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
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)
UltrasoundImagingPositiveFindingResultText
Item
If positive, specify why ultrasound criteria made it positive
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17230 (NCI Thesaurus ObjectClass)
C0041618 (UMLS 2011AA ObjectClass)
LesionAssessmentDate
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Evaluation method, specify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelLymphNodeBiopsyBlueDyeUseInd-2
Item
Was blue dye used
boolean
C15667 (NCI Thesaurus ObjectClass)
C0796693 (UMLS 2011AA ObjectClass)
C461 (NCI Thesaurus Property)
C0013343 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C48333 (NCI Thesaurus Property-3)
C1260957 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SentinelLymphNodeBiopsyTechnetium99mDextranUseInd-2
Item
Was technetium used
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15667 (NCI Thesaurus ObjectClass)
C0796693 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C1243 (NCI Thesaurus Property-2)
C0076028 (UMLS 2011AA Property-2)
LymphNodeDissectionDate
Item
Date of dissection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
Item Group
Footer Module
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

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