ID

11085

Descrizione

CALGB 40503 ELIGIBILITY CHECKLIST NCT00601900 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

18 giugno 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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CALGB 40503 ELIGIBILITY CHECKLIST NCT00601900

Inglese

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

1 moduli  
Header
Descrizione

Header

CALGB Study No
Descrizione

Protocol ID CALGB

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Descrizione

Trial subject ID CALGB

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Patient demographics
Descrizione

Patient demographics

Patient Initials (Last, First Middle)
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Descrizione

Medical Record Number

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Descrizione

Institution Name

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Descrizione

Participating Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Descrizione

Study Number Participating Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Descrizione

Trial subject ID Participating Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
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-2
C25442
UMLS 2011AA ObjectClass-2
C1516238
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25532
UMLS 2011AA Property-2
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Footer Module
Descrizione

Footer Module

Completed by (Last name, First name)
Descrizione

Person Completing Form

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Descrizione

Date Form Completed

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
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
Header
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)
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
Eligibility Criteria
Item
Eligibility criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25442 (NCI Thesaurus ObjectClass-2)
C1516238 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
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
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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