Breast Cancer Registration SWOG S0226 NCT00075764

Southwest Oncology Group Registration Form (S0226) S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer NCT00075764 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C3225DE6-8BA0-26CF-E034-0003BA12F5E7

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  1. StudyEvent: Southwest Oncology Group Registration Form (S0226)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
AssignedTreatmentArm
Item
Assigned Treatment Arm
text
ActivationDate
Item
Activation Date
text
LastAmendedDate
Item
Last Amended Date
text
Patient'sName
Item
Patient's Name
text
SWOGPatientID
Item
SWOG Patient ID
text
OtherGroupPatientNumber
Item
Other Group Patient Number
text
ParticipatingGroupProtocolNumber
Item
Participating Group Protocol Number
text
Caller'sSWOGRosterID
Item
Caller's SWOG Roster ID
text
IRBApprovalDate
Item
IRB Approval Date
text
SWOGInvestigatorNumber
Item
SWOG Investigator Number
text
OtherGroupInvestigatorIdentifierNumber
Item
Other Group Investigator Number (OR)
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
C43359 (NCI Thesaurus ObjectClass-3)
C0441833 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
OtherGroupInvestigatorIdentifierName
Item
Other Group Investigator Name
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
C43359 (NCI Thesaurus ObjectClass-3)
C0441833 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
OtherGroupTreatingInstitutionIdentifierNumber
Item
Other Group Institution Number
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C43359 (NCI Thesaurus ObjectClass-4)
C0441833 (UMLS 2011AA ObjectClass-4)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
OtherGroupTreatingInstitutionIdentifierName
Item
Other Group Institution Name
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C43359 (NCI Thesaurus ObjectClass-4)
C0441833 (UMLS 2011AA ObjectClass-4)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C0018704 (UMLS 2011AA ValueDomain-2)
SWOGTreatingInstitutionNumber
Item
SWOG Treating Institution Number
text
DateHIPAAAuthorizationsigned
Item
Date HIPAA Authorization signed
text
Item
Method of Payment
text
Code List
Method of Payment
CL Item
Private (Private)
CL Item
Medicare (Medicare)
CL Item
Medicare and Private (Medicare and Private)
CL Item
Medicaid (Medicaid)
CL Item
Medicaid and Medicare (Medicaid and Medicare)
CL Item
No insurance (self-pay) (No insurance (self-pay))
CL Item
No insurance (no means) (No insurance (no means))
CL Item
Other, specify at registration (Other, specify at registration)
CL Item
unknown (unknown)
CL Item
Veterans Admin (Veterans Admin)
CL Item
Military (Military)
PatientSocialSecurityNumber
Item
Patient Social Security Number
text
Patient'sZIPCode
Item
Patient's ZIP Code
text
CountryofResidence
Item
Country of Residence
text
SocialInsuranceNumber
Item
Social Insurance Number
text
PostalCode
Item
Postal Code
text
Item Group
Patient data
C2707520 (UMLS CUI-1)
Birth date
Item
Patient's Date of Birth
date
C0421451 (UMLS CUI-1)
Treatment start date
Item
Projected Start Date of Treatment
date
C3173309 (UMLS CUI-1)
Item
Patient Gender
text
C0079399 (UMLS CUI-1)
Code List
Patient Gender
CL Item
Female (Female)
C0086287 (UMLS CUI-1)
CL Item
Male (Male)
C0086582 (UMLS CUI-1)
Item
Patient's Ethnicity
text
C0015031 (UMLS CUI-1)
Code List
Patient's Ethnicity
CL Item
Unknown (Unknown)
CL Item
No (not Spanish) (No (not Spanish))
CL Item
Yes, Mexican (Yes, Mexican)
CL Item
Yes, Puerto Rican (Yes, Puerto Rican)
CL Item
Yes, Cuban (Yes, Cuban)
CL Item
Yes, Central American (Yes, Central American)
CL Item
Yes, South American (Yes, South American)
CL Item
Yes, Other (Yes, Other)
CL Item
Yes, NOS (Yes, NOS)
Item
Patient's Race
text
C0034510 (UMLS CUI-1)
Code List
Patient's Race
CL Item
White or Caucasian (White or Caucasian)
CL Item
Black or African American (Black or African American)
CL Item
Native Hawaiian or Other Pacific Islander (Native Hawaiian or Other Pacific Islander)
CL Item
Asian (Asian)
CL Item
American Indian or Alaska Native (American Indian or Alaska Native)
Prior adjuvant tamoxifen therapy
Item
Prior adjuvant tamoxifen therapy
boolean
Item Group
Consent
C1511481 (UMLS CUI-1)
Informed consent date
Item
Date Informed Consent Signed
date
C2985782 (UMLS CUI-1)
Tissue for cancer research
Item
My tissue may be kept for use in research to learn about, prevent, treat, or cure cancer.
boolean
C0040300 (UMLS CUI-1)
C1516225 (UMLS CUI-2)
Tissue for research
Item
My tissue may be kept for research about other health problems
boolean
C0040300 (UMLS CUI-1)
C0035168 (UMLS CUI-2)
Permission for further contact
Item
Someone from Southwest Oncology Group may contact me in the future to ask me to take part in more research
boolean
C0521104 (UMLS CUI-1)
C2051501 (UMLS CUI-2)
Permission for further contact regarding research
Item
I agree to allow my study doctor, or someone approved by my study doctor, to contact me regard future research involving my participation in this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C0030705 (UMLS CUI-1)
C1519429 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
C1512698 (UMLS CUI-4)
Permission for blood sample fulvestrant
Item
I agree to submit blood samples for the purpose of determining how my body metabolizes the drugs, fulvestrant and anastrozole
boolean
C16960 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C1708 (NCI Thesaurus Property-2)
C19157 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C21198 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C0521104 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0935916 (UMLS CUI-3)
Permission blood sample HER-2
Item
I agree to submit blood samples for the analysis of human epidermal growth factor receptor 2 (HER-2) protein to see if high levels will predict if I am less likely to respond to hormone therapy
boolean
C16960 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C19157 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C17068 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0521104 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0034802 (UMLS CUI-3)
Permission blood sample gene expression
Item
I agree to submit a blood specimen for genetic expression studies to study what role the protocol treatment is having on my disease
boolean
C16960 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C19157 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C16608 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0521104 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0017262 (UMLS CUI-3)
consent tissue specimen
Item
I agree to submit a tissue specimen for the analysis of estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER-2) to see if certain levels will predict if I am likely to respond to hormone therapy
boolean
C16960 (NCI Thesaurus ObjectClass)
C12801 (NCI Thesaurus Property)
C19157 (NCI Thesaurus Property-2)
C17069 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C17068 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1511481 (UMLS CUI-1)
C1292533 (UMLS CUI-2)

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