Breast Cancer NCT00053898 Registration - NSABP PROTOCOL B-35: REGISTRATION FORM - 2033723v3.0

NSABP PROTOCOL B-35: REGISTRATION FORM Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A053033F-8CE7-05B1-E034-080020C9C0E0

Form A (04-30-2002) Prior to randomization, fax Form A and signed consent to 412-383-2065.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1320722 (UMLS CUI-1)
PatientStudyID
Item
Patient Study ID
text
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
InstitutionName
Item
Institution Name
text
NCIInstitutionNumber
Item
Institution Number
text
AffiliateName
Item
Affiliate Name
text
RegisteredInvestigator
Item
Physician of Record (physician to whom study drug will be sent; must have a valid FDA Number)
text
InformedConsentDateSigned
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C2985782 (UMLS CUI-1)
ProjectedTreatmentBeginDate
Item
Projected Start Date of Treatment (Study Drug Month Day Year)
date
PersonCompletingForm,LastName
Item
Person Completing Form Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PersonCompletingForm,Phone
Item
Person Completing Form Phone
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
PersonCompletingForm,Fax
Item
Person Completing Form Fax
float
PatientName
Item
Patient Name (Last, First, MI Last First MI)
text
PatientBirthDate
Item
Patient's Date of Birth (Month Day Year)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Patient'sSocialSecurityNumber
Item
Patient's Social Security Number (USA only)
text
Item
Race Categories
text
Code List
Race Categories
CL Item
White (White)
CL107068 (NCI Metathesaurus)
CL Item
Black or African American (Black or African American)
CL Item
Black (Black)
CL Item
Native Hawaiian Or Other Pacific Islander (Native Hawaiian or Other Pacific Islander)
CL025744 (NCI Metathesaurus)
CL Item
Asian (Asian)
CL106519 (NCI Metathesaurus)
CL Item
American Indian Or Alaska Native (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnic Categories
text
Code List
Ethnic Categories
CL Item
Hispanic Or Latino (Hispanic or Latino)
CL024968 (NCI Metathesaurus)
CL Item
Hispanic (Hispanic)
CL Item
Non-hispanic (Non-Hispanic)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Method of Payment
text
Code List
Method of Payment
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
CL Item
Medicare & Private (Medicare & Private)
CL Item
Medicaid (Medicaid)
CL Item
Medicaid & Medicare (Medicaid & Medicare)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Military or Veterans Sponsored NOS (Military or Veterans Sponsored NOS)
CL Item
Military Sponsored (incl. CHAMPUS & TRICARE) (Military Sponsored (incl. CHAMPUS & TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self pay (no insurance) (Self pay (no insurance))
CL Item
No means of payment (no insurance) (No means of payment (no insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Country of Residence (if not USA)
text
Code List
Country of Residence (if not USA)
CL Item
Canada (Canada)
CL Item
Mexico (Mexico)
CL Item
Puerto Rico (Puerto Rico)
CL Item
Other (Other)
OtherInd-3
Item
Other
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
PatientAddress,PostalCode
Item
Patient's zip code (USA)
text
Item Group
Item
Performance Status
integer
C0206065 (UMLS CUI-1)
Code List
Performance Status
CL Item
Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100) (0)
CL Item
Restricted in physically strenous activity but ambulatory (K 70-80) (1)
CL Item
Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60) (2)
CL Item
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40) (3)
CL Item
Completely disabled (K 10-20) (4)
Age
Item
Age at Registration
integer
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0001779 (UMLS CUI-1)
PatientHeight
Item
Patient Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0030705 (UMLS CUI-1)
C0489786 (UMLS CUI-2)
PatientWeight
Item
Patient Weight
float
C0005910 (UMLS CUI-1)
WBC
Item
WBC
float
C0023508 (UMLS CUI-1)
SGOT (AST)
Item
SGOT (AST)
float
C25180 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI-1)
Totalbilirubin
Item
Total bilirubin
float
C25180 (NCI Thesaurus ValueDomain)
C0201913 (UMLS CUI-1)
AlkalinePhosphatase
Item
Alkaline phosphatase
float
C25180 (NCI Thesaurus ValueDomain)
C0201850 (UMLS CUI-1)
Serumcreatinine
Item
Serum creatinine
float
C25180 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI-1)
Item Group
Eligibility Checklist
PatientEligibilityInd
Item
In the opinion of the investigator, is the patient eligible?
boolean
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS CUI-1)
Item
Verification of Postmenopausal Status (Select the item that best describes the patient.)
integer
C38008 (NCI Thesaurus Property)
C3231 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus ObjectClass)
C2911173 (UMLS CUI-1)
Code List
Verification of Postmenopausal Status (Select the item that best describes the patient.)
CL Item
Bilateral Oophorectomy (1)
CL Item
No Bilateral Oophorectomy And No Hysterectomy: And > 12 Months Since LMP (2)
CL Item
Hysterectomy But No Bilateral Oophorectomy: And Age at least 55 At Randomization (3)
CL Item
Hysterectomy But No Bilateral Oophorectomy: And Age below 55 At Randomization And FSH Within The Postmenopausal Range As Determined By The Investigator (4)
CL Item
None Of The Above (ineligible) (5)
Date of Last Surgery for Breast Cancer Treatment
Item
Date of Last Surgery for Breast Cancer Treatment (Must be within 84 days of randomization)
date
Item Group
Surgical Treatment And Pathology
Lumpectomy
Item
Did the patient undergo lumpectomy?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0851238 (UMLS CUI-1)
Invasive breast cancer
Item
Was the patient diagnosed with invasive or microinvasive breast cancer?
boolean
C0853879 (UMLS CUI-1)
DCIS
Item
Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?
boolean
C25458 (NCI Thesaurus Property)
C2924 (NCI Thesaurus ObjectClass)
C25527 (NCI Thesaurus Property-2)
C0007124 (UMLS CUI-1)
Margins free of DCIS
Item
Are the final margins of the resected specimen histologically free of DCIS?
boolean
C25508 (NCI Thesaurus ObjectClass)
C25563 (NCI Thesaurus ObjectClass-2)
C25547 (NCI Thesaurus Property)
C25527 (NCI Thesaurus Property-2)
C25180 (NCI Thesaurus ValueDomain)
Suspicious masses
Item
Were there any clinically or mammographically suspicious masses or clusters of calcification?
boolean
C25180 (NCI Thesaurus ValueDomain)
Biopsy of suspicious masses
Item
If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?
boolean
C25180 (NCI Thesaurus ValueDomain)
Margins free of DCIS
Item
If item 5a is yes, are the margins histologically free of DCIS?
boolean
C25180 (NCI Thesaurus ValueDomain)
lymph nodes
Item
Are there suspicious palpable nodes in the ipsilateral or contralateral axilla? ([If item 6 is yes, attach pathologic documentation that these are not involved with tumor])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0024204 (UMLS CUI-1)
Lymph nodes palpable supraclavicular or infraclavicular
Item
Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0241306 (UMLS CUI-1)
C0229743 (UMLS CUI-2)
Bilateral Malignancy
Item
Is there a bilateral malignancy or a mass or mammographic abnormality in the opposite breast that is suspicious for malignancy? ([If item 8 is yes, attach pathologic documentation that this is not malignant])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0677861 (UMLS CUI-1)
Lymph node positive ipsilateral
Item
Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0746319 (UMLS CUI-1)
C0441989 (UMLS CUI-2)
Mastectomy
Item
Did the patient undergo mastectomy?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0024881 (UMLS CUI-1)
Item Group
Other Treatment
Systemic or radiation therapy
Item
Has systemic or radiation therapy been given for the current DCIS?
boolean
C25180 (NCI Thesaurus ValueDomain)
Prior Hormonal Therapy
Item
Has the patient previously taken, or is the patient currently taking, aromatase inhibitors or tamoxifen for treatment or prevention of any disease?
boolean
Selective Estrogen Receptor Modulators (SERM)
Item
Is the patient currently taking raloxifene (Evista [R])or other selective estrogen receptor modulators (SERMs)? ([Circle "no" if this therapy is discontinued prior to randomization.])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0732611 (UMLS CUI-1)
Sex hormonal therapy
Item
Has the patient been taking any sex hormonal therapy, e.g. estrogen or progesterone replacement therapy, oral contraceptives, androgens, etc.? ([See Protocol, Section 5.2.11])
boolean
C25180 (NCI Thesaurus ValueDomain)
Therapy discontinued prior to randomization
Item
If item 14 is yes, was this therapy discontinued prior to randomization?
boolean
C25180 (NCI Thesaurus ValueDomain)
Item Group
Contraindications
Non-breast malignancy
Item
Has the patient ever been diagnosed with a non-breast malignancy?
boolean
C25180 (NCI Thesaurus ValueDomain)
Disease-free for at least 5 years
Item
If item 16 is yes, has the patient been disease-free for at least 5 years?
boolean
C25180 (NCI Thesaurus ValueDomain)
Skin carcinoma, cervix carcinoma or LCIS
Item
If item 16a is no, was the diagnosis squamous or basal cell carcinoma of the skin which was effectively treated, carcinoma in situ of the cervix that has been treated by surgery alone, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast
boolean
C25180 (NCI Thesaurus ValueDomain)
TIA or cerebrovascular accident
Item
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
boolean
C29867 (NCI Thesaurus ObjectClass)
C50781 (NCI Thesaurus Property)
C3390 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0007787 (UMLS CUI-1)
C0038454 (UMLS CUI-2)
Systemic disease, non-malignant
Item
Does the patient have a nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude her being subjected to protocol therapy or would prevent prolonged follow-up?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0442893 (UMLS CUI-1)
C1518371 (UMLS CUI-2)
Psychiatric disorders
Item
Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0004936 (UMLS CUI-1)
Prior history of invasive breast cancer or DCIS
Item
Does the patient have a prior history of invasive breast cancer or DCIS?
boolean
C25180 (NCI Thesaurus ValueDomain)
Hypertension, uncontrolled
Item
Does the patient have uncontrolled hypertension?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1868885 (UMLS CUI-1)
Diabetes mellitus uncontrolled
Item
Does the patient have uncontrolled diabetes?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0743131 (UMLS CUI-1)
Atrial fibrillation
Item
Does the patient have atrial fibrillation, not controlled by medication?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0004238 (UMLS CUI-1)
Item Group
Pre-entry Studies
History and physical past 6 months
Item
Has the patient had a history and physical in the last 6 months?
boolean
C25180 (NCI Thesaurus ValueDomain)
Mammogram past 12 months
Item
Has the patient had a bilateral mammogram within the past 12 months?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0024671 (UMLS CUI-1)
C3843288 (UMLS CUI-2)
Hysterectomy
Item
Has the patient had a hysterectomy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS CUI-1)
Pelvic exam past 12 months
Item
If item 26 is no, has the patient had a pelvic exam within the past 12 months?
boolean
C25180 (NCI Thesaurus ValueDomain)

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