ID

1044

Descrizione

CALGB 40503 ELIGIBILITY CHECKLIST Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2DB1C326-547F-15B1-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2DB1C326-547F-15B1-E044-0003BA3F9857

Keywords

versioni (3)
  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 18/06/15 18/06/15 -
Caricato su

26 agosto 2012

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00601900 Eligibility - CALGB 40503 ELIGIBILITY CHECKLIST - 2625904v1.0

Inglese

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

1 moduli  
Unnamed1
Descrizione

Unnamed1

CALGB Study No
Descrizione

ProtocolCALGBIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
CALGB Patient ID
Descrizione

PatientCALGBIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
Unnamed2
Descrizione

Unnamed2

Patient Initials (Last, First Middle)
Descrizione

PatientInitialsName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Hospital No.
Descrizione

PatientMedicalRecordNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Institution/Affiliate
Descrizione

CombinedInstitutionName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participating Group
Descrizione

ParticipatingGroupName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
Descrizione

ProtocolParticipatingIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Descrizione

PatientParticipatingIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Eligibility Criteria
Descrizione

Eligibility Criteria

Eligibility criteria
Descrizione

CancerandLeukemiaGroupBPatientInclusionClinicalTrialEligibilityCriteria40503Type

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C25442
UMLS 2011AA ObjectClass
C1516238
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25532
UMLS 2011AA Property
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Footer Module
Descrizione

Footer Module

Completed by (Last name, First name)
Descrizione

ResponsiblePersonName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Form Completed (MM DD YYYY)
Descrizione

FormCompleteDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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Similar models

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

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Unnamed1
ProtocolCALGBIdentifierNumber
Item
CALGB Study No
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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First Middle)
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)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Eligibility Criteria
Item
Eligibility criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.1
Code List
Eligibility criteria
CL Item
>= 18 Years Of Age (>= 18 years of age)
CL Item
>= 2 Weeks Since Prior Radiotherapy And All Toxicities Resolved (>= 2 weeks since prior radiotherapy and all toxicities resolved)
CL Item
Beta-hcg Negative (in Premenopausal Women) (Beta-Hcg negative (in premenopausal women))
CL Item
Bilirubin <= 1.5 X Uln Unless Due To Gilbert's Syndrome (Bilirubin <= 1.5 x ULN unless due to Gilbert's Syndrome)
CL Item
Bisphosphonate Therapy Allowed (Bisphosphonate therapy allowed)
CL Item
Creatinine <= 2.0 Mg/dl (Creatinine <= 2.0 mg/dl)
CL Item
Ecog (zubrod) Ps <= 1; Life Expectancy >=12 Wk (ECOG (Zubrod) PS <= 1; life expectancy >=12 wk)
CL Item
Granulocytes >= 1000/ul (Granulocytes >= 1000/ul)
CL Item
Histologic Dx Of Primary, Metastatic Stage Iv Or Locally Advanced, Unresectable Stage Iiib Cancer Of The Female Breast (using Ajcc Criteria, 6th Edition) Not Amenable To Local Therapy (Histologic dx of primary, metastatic Stage IV or locally advanced, unresectable Stage IIIB cancer of the female breast (using AJCC criteria, 6th edition) not amenable to local therapy)
CL Item
Inr <= 1.6, Unless On Full Dose Warfarin (INR <= 1.6, unless on full dose warfarin)
CL Item
Measurable/non-measurable Disease By Recist Criteria (Measurable/non-measurable disease by RECIST criteria)
CL Item
No Arterial Thrombotic Events, Tia, Cva, Acute Mi Or Unstable Angina Within 6 Months Of Registration (No arterial thrombotic events, TIA, CVA, acute MI or unstable angina within 6 months of registration)
CL Item
No Clinically Significant Cardiovascular Disease (No clinically significant cardiovascular disease)
CL Item
No Concurrent Active Secondary Malignancy (No concurrent active secondary malignancy)
CL Item
No History Of Abdominal Fistula Or Intraabdominal Abscess Within 6 Months Nor Gi Perforation Within 12 Months Of Registration (No history of abdominal fistula or intraabdominal abscess within 6 months nor GI perforation within 12 months of registration)
CL Item
No History Of Significant Bleeding Within 6 Months Of Registration (No history of significant bleeding within 6 months of registration)
CL Item
No Known Allergies To Aromatase Inhibitors Or Estrogen Receptor Modulators (No known allergies to aromatase inhibitors or estrogen receptor modulators)
CL Item
No Known Cns Metastases (No known CNS metastases)
CL Item
No Major Surgery Within 28 Days Of Registration (No major surgery within 28 days of registration)
CL Item
No Prior Bevacizumab Or Anti-vegf Therapy (No prior bevacizumab or anti-VEGF therapy)
CL Item
No Prior Chemotherapy For Metastatic Disease (No prior chemotherapy for metastatic disease)
CL Item
No Serious, Non-healing Wound, Ulcer Or Bone Fx (No serious, non-healing wound, ulcer or bone fx)
CL Item
Ovarian Suppression Required For Premenopausal Women (Ovarian suppression required for premenopausal women)
CL Item
Patients On Full Dose Anticoagulant Must Be On A Stable Dose Of Warfarin (Patients on full dose anticoagulant must be on a stable dose of warfarin)
CL Item
Platelet Count >= 100,000/ul (Platelet count >= 100,000/ul)
CL Item
Prior Adjuvant Or Neoadjuvant Chemotherapy Allowed (Prior adjuvant or neoadjuvant chemotherapy allowed)
CL Item
Prior Endocrine Therapy Not Required, But Is Permitted In Adjuvant Setting; No Prior Endocrine Therapy For Metastatic Disease Unless Initiated Within 4 Weeks Prior To Protocol Registration (Prior endocrine therapy not required, but is permitted in adjuvant setting; No prior endocrine therapy for metastatic disease unless initiated within 4 weeks prior to protocol registration)
CL Item
Transaminases (alt, Ast) <= 2.5 X Uln (Transaminases (ALT, AST) <= 2.5 x ULN)
CL Item
Tumors That Are Er And/or Pgr Positive (Tumors that are ER and/or PgR positive)
CL Item
Urinalysis <= 1+ Protein (Urinalysis <= 1+ protein)
CL Item
Women Can Be Either Pre- Or Postmenopausal (Women can be either pre- or postmenopausal)
Item Group
Footer Module
ResponsiblePersonName
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
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