ID

775

Beschreibung

CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4CFBF75-6AD3-69D3-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4CFBF75-6AD3-69D3-E034-080020C9C0E0

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 08.07.15 08.07.15 -
  3. 08.07.15 08.07.15 -
Hochgeladen am

26. August 2012

DOI

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Breast Cancer NCT00041119 Eligibility - CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST - 2039130v3.0

Englisch

INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.

1 Formulare  
Unnamed1
Beschreibung

Unnamed1

CALGB Study No.
Beschreibung

CALGBProtocolNumber

Datentyp

text

CALGB Patient ID
Beschreibung

CALGBPatientID

Datentyp

text

Unnamed2
Beschreibung

Unnamed2

Patient's Name
Beschreibung

Patient'sName

Datentyp

text

Participating Group
Beschreibung

ParticipatingGroup

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Beschreibung

PatientHospitalNumber

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Main Member Institution/Adjunct
Beschreibung

MainMemberInstitution/Adjunct

Datentyp

text

Participating Group Patient No.
Beschreibung

ParticipatingGroupPatientNo.

Datentyp

text

Unnamed3
Beschreibung

Unnamed3

Histologically confirmed invasive carcinoma of the breast
Beschreibung

Histologicallyconfirmedinvasivecarcinomaofthebreast

Datentyp

text

Undergone either modified radical mastectomy or lumpectomy
Beschreibung

Undergoneeithermodifiedradicalmastectomyorlumpectomy

Datentyp

text

Negative tumor margins for invasive cancer and DCIS in case of mastectomy or lumpectomy
Beschreibung

NegativetumormarginsforinvasivecancerandDCISincaseofmastectomyorlumpectomy

Datentyp

text

No locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer
Beschreibung

Nolocallyadvancedbreastcancer,inflammatorybreastcancerormetastaticbreastcancer

Datentyp

text

No involvement of dermal lymphatics on pathology
Beschreibung

Noinvolvementofdermallymphaticsonpathology

Datentyp

text

"High-risk" node-negative breast cancer (guidelines are ER/PgR positive primary tumor >= 1 cm in greatest diameter, or ER/PgR negative tumor of any size; physician discretion is allowed)
Beschreibung

"High-risk"node-negativebreastcancer

Datentyp

text

Negative sentinel node biopsy, and/or an axillary dissection where at least 6 lymph nodes are removed and found to be negative
Beschreibung

Negativesentinelnodebiopsy,and/oranaxillarydissectionwhereatleast6lymphnodesareremovedandfoundtobenegative

Datentyp

text

No previous chemotherapy or hormonal therapy (except for tamoxifen as described in the protocol) for this malignancy
Beschreibung

Nopreviouschemotherapyorhormonaltherapy(exceptfortamoxifenasdescribedintheprotocol)forthismalignancy

Datentyp

text

Age >= 18 years
Beschreibung

Age>=18years

Datentyp

text

CTC Performance status 0-1
Beschreibung

CTCPerformancestatus0-1

Datentyp

text

Non-pregnant and non-nursing
Beschreibung

Non-pregnantandnon-nursing

Datentyp

text

No active congestive heart failure nor myocardial infarction within 6 months prior to registration
Beschreibung

Noactivecongestiveheartfailurenormyocardialinfarctionwithin6monthspriortoregistration

Datentyp

text

Disease-free of prior invasive malignancies for >5 years except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Beschreibung

Disease-freeofpriorinvasivemalignanciesfor>5yearsexceptforcurativelytreatedbasalcellorsquamouscellcarcinomaoftheskinorcarcinomainsituofthecervix

Datentyp

text

Willing to stop exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene
Beschreibung

Willingtostopexogenoushormonetherapy,includingoralcontraceptives,post-menopausalhormonereplacementtherapy,andraloxifene

Datentyp

text

Discontinued tamoxifen at time of enrollment to study if tamoxifen has been received as breast cancer preventive agent, or as treatment for this malignancy for <= 4 weeks. (If latter, indicate dates below)
Beschreibung

Discontinuedtamoxifenattimeofenrollmenttostudyiftamoxifenhasbeenreceivedasbreastcancerpreventiveagent,orastreatmentforthismalignancyfor<=4weeks.

Datentyp

text

Date tamoxifen started
Beschreibung

Datetamoxifenstarted

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date tamoxifen discontinued
Beschreibung

Datetamoxifendiscontinued

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Meets ALL of the following laboratory criteria completed within 16 days before registration
Beschreibung

MeetsALLofthefollowinglaboratorycriteriacompletedwithin16daysbeforeregistration

Datentyp

text

ANC >= 1000/mcL
Beschreibung

ANC>=1000/mcL

Datentyp

text

Date obtained (ANC)
Beschreibung

Dateobtained(ANC)

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Platelets >= 100,000/mcL
Beschreibung

Platelets>=100,000/mcL

Datentyp

text

Date obtained (Platelets)
Beschreibung

Dateobtained(Platelets)

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Creatinine <= 2.0 mg/dL
Beschreibung

Creatinine<=2.0mg/dL

Datentyp

text

Date obtained (Creatinine)
Beschreibung

Dateobtained(Creatinine)

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)
Beschreibung

TotalBilirubin<1.5xupperlimitsofnormaloflaboratory

Datentyp

text

Date obtained (Total Bilirubin)
Beschreibung

Dateobtained(TotalBilirubin)

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
ULN (Total Bilirubin)
Beschreibung

ULN(TotalBilirubin)

Datentyp

text

<= 84 days since last major breast surgery
Beschreibung

<=84dayssincelastmajorbreastsurgery

Datentyp

text

Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist
Beschreibung

Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist

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Ähnliche Modelle

INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
CALGBProtocolNumber
Item
CALGB Study No.
text
CALGBPatientID
Item
CALGB Patient ID
text
Item Group
Unnamed2
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
Item Group
Unnamed3
Histologicallyconfirmedinvasivecarcinomaofthebreast
Item
Histologically confirmed invasive carcinoma of the breast
text
Undergoneeithermodifiedradicalmastectomyorlumpectomy
Item
Undergone either modified radical mastectomy or lumpectomy
text
NegativetumormarginsforinvasivecancerandDCISincaseofmastectomyorlumpectomy
Item
Negative tumor margins for invasive cancer and DCIS in case of mastectomy or lumpectomy
text
Nolocallyadvancedbreastcancer,inflammatorybreastcancerormetastaticbreastcancer
Item
No locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer
text
Noinvolvementofdermallymphaticsonpathology
Item
No involvement of dermal lymphatics on pathology
text
"High-risk"node-negativebreastcancer
Item
"High-risk" node-negative breast cancer (guidelines are ER/PgR positive primary tumor >= 1 cm in greatest diameter, or ER/PgR negative tumor of any size; physician discretion is allowed)
text
Negativesentinelnodebiopsy,and/oranaxillarydissectionwhereatleast6lymphnodesareremovedandfoundtobenegative
Item
Negative sentinel node biopsy, and/or an axillary dissection where at least 6 lymph nodes are removed and found to be negative
text
Nopreviouschemotherapyorhormonaltherapy(exceptfortamoxifenasdescribedintheprotocol)forthismalignancy
Item
No previous chemotherapy or hormonal therapy (except for tamoxifen as described in the protocol) for this malignancy
text
Age>=18years
Item
Age >= 18 years
text
CTCPerformancestatus0-1
Item
CTC Performance status 0-1
text
Non-pregnantandnon-nursing
Item
Non-pregnant and non-nursing
text
Noactivecongestiveheartfailurenormyocardialinfarctionwithin6monthspriortoregistration
Item
No active congestive heart failure nor myocardial infarction within 6 months prior to registration
text
Disease-freeofpriorinvasivemalignanciesfor>5yearsexceptforcurativelytreatedbasalcellorsquamouscellcarcinomaoftheskinorcarcinomainsituofthecervix
Item
Disease-free of prior invasive malignancies for >5 years except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
text
Willingtostopexogenoushormonetherapy,includingoralcontraceptives,post-menopausalhormonereplacementtherapy,andraloxifene
Item
Willing to stop exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene
text
Discontinuedtamoxifenattimeofenrollmenttostudyiftamoxifenhasbeenreceivedasbreastcancerpreventiveagent,orastreatmentforthismalignancyfor<=4weeks.
Item
Discontinued tamoxifen at time of enrollment to study if tamoxifen has been received as breast cancer preventive agent, or as treatment for this malignancy for <= 4 weeks. (If latter, indicate dates below)
text
Datetamoxifenstarted
Item
Date tamoxifen started
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Datetamoxifendiscontinued
Item
Date tamoxifen discontinued
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
MeetsALLofthefollowinglaboratorycriteriacompletedwithin16daysbeforeregistration
Item
Meets ALL of the following laboratory criteria completed within 16 days before registration
text
ANC>=1000/mcL
Item
ANC >= 1000/mcL
text
Dateobtained(ANC)
Item
Date obtained (ANC)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Platelets>=100,000/mcL
Item
Platelets >= 100,000/mcL
text
Dateobtained(Platelets)
Item
Date obtained (Platelets)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Creatinine<=2.0mg/dL
Item
Creatinine <= 2.0 mg/dL
text
Dateobtained(Creatinine)
Item
Date obtained (Creatinine)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
TotalBilirubin<1.5xupperlimitsofnormaloflaboratory
Item
Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)
text
Dateobtained(TotalBilirubin)
Item
Date obtained (Total Bilirubin)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ULN(TotalBilirubin)
Item
ULN (Total Bilirubin)
text
<=84dayssincelastmajorbreastsurgery
Item
<= 84 days since last major breast surgery
text
Item Group
Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist
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