ID

11614

Description

CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST NCT00041119 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

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 7/8/15 7/8/15 -
  3. 7/8/15 7/8/15 -
Uploaded on

July 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST NCT00041119

English

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

1 forms  
Header module
Description

Header module

CALGB Study No.
Description

CALGB Study No.

Data type

integer

Alias
UMLS CUI-1
C1516238
UMLS CUI-2
C2603343
CALGB Patient ID
Description

CALGB Patient ID

Data type

text

Alias
UMLS CUI-1
C1516238
UMLS CUI-2
C0030692
Patient's Name
Description

Patient's Name

Data type

text

Alias
UMLS CUI-1
C1299487
Participating Group
Description

ParticipatingGroup

Data type

text

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

Patient Hospital Number

Data type

integer

Alias
UMLS CUI-1
C0421459
Participating Group Protocol No.
Description

Participating Group Protocol No.

Data type

integer

Alias
UMLS CUI-1
C0332037
UMLS CUI-2
C0237753
Main Member Institution/Adjunct
Description

Main Member Institution/Adjunct

Data type

text

Alias
UMLS CUI-1
C0680022
UMLS CUI-2
C2607850
Participating Group Patient No.
Description

Participating Group Patient No.

Data type

text

Alias
UMLS CUI-1
C0687744
UMLS CUI-2
C0600091
Breast Cancer ELIGIBILITY
Description

Breast Cancer ELIGIBILITY

Histologically confirmed invasive carcinoma of the breast
Description

Histologically confirmed invasive carcinoma of the breast

Data type

boolean

Alias
UMLS CUI-1
C0853879
Undergone either modified radical mastectomy or lumpectomy
Description

Undergone either modified radical mastectomy or lumpectomy

Data type

boolean

Alias
UMLS CUI-1
C0024884
UMLS CUI-2
C0740370
Negative tumor margins for invasive cancer and DCIS in case of mastectomy or lumpectomy
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0332648
No locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0006142
UMLS CUI-2
C0278601
UMLS CUI-3
C0278488
No involvement of dermal lymphatics on pathology
Description

No involvement of dermal lymphatics on pathology

Data type

boolean

Alias
UMLS CUI-1
C0024235
UMLS CUI-2
C0221928
UMLS CUI-3
C1314939
"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)
Description

"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)

Data type

boolean

Alias
UMLS CUI-1
C0006142
UMLS CUI-2
C0332167
UMLS CUI-3
C2371027
Negative sentinel node biopsy, and/or an axillary dissection where at least 6 lymph nodes are removed and found to be negative
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0796693
UMLS CUI-2
C0193867
<= 84 days since last major breast surgery
Description

<= 84 days since last major breast surgery

Data type

boolean

Alias
UMLS CUI-1
C0851312
UMLS CUI-2
C3646033
No previous chemotherapy or hormonal therapy (except for tamoxifen as described in the protocol) for this malignancy
Description

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

Data type

boolean

Alias
UMLS CUI-1
C3665472
UMLS CUI-2
C0279025
Age >= 18 years
Description

Age >= 18 years

Data type

boolean

Alias
UMLS CUI-1
C0001779
CTC Performance status 0-1
Description

CTC Performance status 0-1

Data type

boolean

Alias
UMLS CUI-1
C0027625
UMLS CUI-2
C1518965
Non-pregnant and non-nursing
Description

Non-pregnant and non-nursing

Data type

boolean

Alias
UMLS CUI-1
C0232973
UMLS CUI-2
C0006147
No active congestive heart failure nor myocardial infarction within 6 months prior to registration
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0018802
UMLS CUI-2
C0027051
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
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0242793
UMLS CUI-2
C0677898
Willing to stop exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0600109
UMLS CUI-2
C1516999
UMLS CUI-3
C2746065
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)
Description

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)

Data type

boolean

Alias
UMLS CUI-1
C0039286
UMLS CUI-2
C1444662
Date tamoxifen started
Description

Date tamoxifen started

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C3173309
UMLS CUI-2
C0039286
Date tamoxifen discontinued
Description

Date tamoxifen discontinued

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0039286
UMLS CUI-2
C2826748
Meets ALL of the following laboratory criteria completed within 16 days before registration
Description

Meets ALL of the following laboratory criteria completed within 16 days before registration

Data type

boolean

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0243161
ANC >= 1000/mcL
Description

ANC >= 1000/mcL

Data type

boolean

Alias
UMLS CUI-1
C0948762
UMLS CUI-2
C0439378
Date obtained (ANC)
Description

Date obtained (ANC)

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0948762
UMLS CUI-2
C1277697
Platelets >= 100,000/mcL
Description

Platelets >= 100,000/mcL

Data type

boolean

Alias
UMLS CUI-1
C0032181
UMLS CUI-2
C0439378
Date obtained (Platelets)
Description

Date obtained (Platelets)

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1277697
UMLS CUI-2
C0032181
Creatinine <= 2.0 mg/dL
Description

Creatinine <= 2.0 mg/dL

Data type

boolean

Alias
UMLS CUI-1
C0201975
UMLS CUI-2
C0439269
Date obtained (Creatinine)
Description

Date obtained (Creatinine)

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1277697
UMLS CUI-2
C0201975
Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)
Description

Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)

Data type

boolean

Alias
UMLS CUI-1
C0201913
UMLS CUI-2
C0439269
Date obtained (Total Bilirubin)
Description

Date obtained (Total Bilirubin)

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1277697
UMLS CUI-2
C0201913
ULN (Total Bilirubin)
Description

ULN (Total Bilirubin)

Data type

integer

Alias
UMLS CUI-1
C1519815
UMLS CUI-2
C0201913
Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist
Description

Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist

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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
CALGB Protocol Number
Item
CALGB Study No.
integer
C1516238 (UMLS CUI-1)
C2603343 (UMLS CUI-2)
CALGB Patient ID
Item
CALGB Patient ID
text
C1516238 (UMLS CUI-1)
C0030692 (UMLS CUI-2)
Patient's Name
Item
Patient's Name
text
C1299487 (UMLS CUI-1)
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Patient Hospital Number
Item
Patient Hospital Number
integer
C0421459 (UMLS CUI-1)
Participating Group Protocol No.
Item
Participating Group Protocol No.
integer
C0332037 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Main Member Institution/Adjunct
Item
Main Member Institution/Adjunct
text
C0680022 (UMLS CUI-1)
C2607850 (UMLS CUI-2)
Participating Group Patient No.
Item
Participating Group Patient No.
text
C0687744 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
Item Group
Breast Cancer ELIGIBILITY
Invasive carcinoma of the breast
Item
Histologically confirmed invasive carcinoma of the breast
boolean
C0853879 (UMLS CUI-1)
Radical mastectomy or lumpectomy
Item
Undergone either modified radical mastectomy or lumpectomy
boolean
C0024884 (UMLS CUI-1)
C0740370 (UMLS CUI-2)
Negative tumor margins
Item
Negative tumor margins for invasive cancer and DCIS in case of mastectomy or lumpectomy
boolean
C0332648 (UMLS CUI-1)
No locally advanced breast cancer
Item
No locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer
boolean
C0006142 (UMLS CUI-1)
C0278601 (UMLS CUI-2)
C0278488 (UMLS CUI-3)
Dermal lymphatics involvement
Item
No involvement of dermal lymphatics on pathology
boolean
C0024235 (UMLS CUI-1)
C0221928 (UMLS CUI-2)
C1314939 (UMLS CUI-3)
High-risk node-negative breast cancer
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)
boolean
C0006142 (UMLS CUI-1)
C0332167 (UMLS CUI-2)
C2371027 (UMLS CUI-3)
Negative sentinel node
Item
Negative sentinel node biopsy, and/or an axillary dissection where at least 6 lymph nodes are removed and found to be negative
boolean
C0796693 (UMLS CUI-1)
C0193867 (UMLS CUI-2)
<= 84 days since last major breast surgery
Item
<= 84 days since last major breast surgery
boolean
C0851312 (UMLS CUI-1)
C3646033 (UMLS CUI-2)
No previous chemotherapy or hormonal therapy
Item
No previous chemotherapy or hormonal therapy (except for tamoxifen as described in the protocol) for this malignancy
boolean
C3665472 (UMLS CUI-1)
C0279025 (UMLS CUI-2)
Age>=18years
Item
Age >= 18 years
boolean
C0001779 (UMLS CUI-1)
CTC Performance status
Item
CTC Performance status 0-1
boolean
C0027625 (UMLS CUI-1)
C1518965 (UMLS CUI-2)
Non-pregnantandnon-nursing
Item
Non-pregnant and non-nursing
boolean
C0232973 (UMLS CUI-1)
C0006147 (UMLS CUI-2)
No active congestive heart failure
Item
No active congestive heart failure nor myocardial infarction within 6 months prior to registration
boolean
C0018802 (UMLS CUI-1)
C0027051 (UMLS CUI-2)
Disease-free of prior invasive malignancies
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
boolean
C0242793 (UMLS CUI-1)
C0677898 (UMLS CUI-2)
Willing to stop exogenous hormone therapy
Item
Willing to stop exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene
boolean
C0600109 (UMLS CUI-1)
C1516999 (UMLS CUI-2)
C2746065 (UMLS CUI-3)
Discontinued tamoxifen
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)
boolean
C0039286 (UMLS CUI-1)
C1444662 (UMLS CUI-2)
Date tamoxifen started
Item
Date tamoxifen started
date
C25164 (NCI Thesaurus ValueDomain)
C3173309 (UMLS CUI-1)
C0039286 (UMLS CUI-2)
Date tamoxifen discontinued
Item
Date tamoxifen discontinued
date
C25164 (NCI Thesaurus ValueDomain)
C0039286 (UMLS CUI-1)
C2826748 (UMLS CUI-2)
laboratory criteria
Item
Meets ALL of the following laboratory criteria completed within 16 days before registration
boolean
C0022877 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
ANC>=1000/mcL
Item
ANC >= 1000/mcL
boolean
C0948762 (UMLS CUI-1)
C0439378 (UMLS CUI-2)
Date obtained (ANC)
Item
Date obtained (ANC)
date
C25164 (NCI Thesaurus ValueDomain)
C0948762 (UMLS CUI-1)
C1277697 (UMLS CUI-2)
Platelets >= 100,000/mcL
Item
Platelets >= 100,000/mcL
boolean
C0032181 (UMLS CUI-1)
C0439378 (UMLS CUI-2)
Date obtained (Platelets)
Item
Date obtained (Platelets)
date
C25164 (NCI Thesaurus ValueDomain)
C1277697 (UMLS CUI-1)
C0032181 (UMLS CUI-2)
Creatinine <= 2.0 mg/dL
Item
Creatinine <= 2.0 mg/dL
boolean
C0201975 (UMLS CUI-1)
C0439269 (UMLS CUI-2)
Dateobtained(Creatinine)
Item
Date obtained (Creatinine)
date
C25164 (NCI Thesaurus ValueDomain)
C1277697 (UMLS CUI-1)
C0201975 (UMLS CUI-2)
Total Bilirubin
Item
Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)
boolean
C0201913 (UMLS CUI-1)
C0439269 (UMLS CUI-2)
Date obtained (TotalBilirubin)
Item
Date obtained (Total Bilirubin)
date
C25164 (NCI Thesaurus ValueDomain)
C1277697 (UMLS CUI-1)
C0201913 (UMLS CUI-2)
ULN( Tota lBilirubin)
Item
ULN (Total Bilirubin)
integer
C1519815 (UMLS CUI-1)
C0201913 (UMLS CUI-2)
Item Group
Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist
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