ID
11614
Beschrijving
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
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- 26-08-12 26-08-12 -
- 08-07-15 08-07-15 -
- 08-07-15 08-07-15 -
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8 juli 2015
DOI
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Creative Commons BY-NC 3.0 Legacy
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CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST NCT00041119
INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.
- StudyEvent: CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST
Beschrijving
Breast Cancer ELIGIBILITY
Beschrijving
Histologically confirmed invasive carcinoma of the breast
Datatype
boolean
Alias
- UMLS CUI-1
- C0853879
Beschrijving
Undergone either modified radical mastectomy or lumpectomy
Datatype
boolean
Alias
- UMLS CUI-1
- C0024884
- UMLS CUI-2
- C0740370
Beschrijving
Negative tumor margins for invasive cancer and DCIS in case of mastectomy or lumpectomy
Datatype
boolean
Alias
- UMLS CUI-1
- C0332648
Beschrijving
No locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer
Datatype
boolean
Alias
- UMLS CUI-1
- C0006142
- UMLS CUI-2
- C0278601
- UMLS CUI-3
- C0278488
Beschrijving
No involvement of dermal lymphatics on pathology
Datatype
boolean
Alias
- UMLS CUI-1
- C0024235
- UMLS CUI-2
- C0221928
- UMLS CUI-3
- C1314939
Beschrijving
"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)
Datatype
boolean
Alias
- UMLS CUI-1
- C0006142
- UMLS CUI-2
- C0332167
- UMLS CUI-3
- C2371027
Beschrijving
Negative sentinel node biopsy, and/or an axillary dissection where at least 6 lymph nodes are removed and found to be negative
Datatype
boolean
Alias
- UMLS CUI-1
- C0796693
- UMLS CUI-2
- C0193867
Beschrijving
<= 84 days since last major breast surgery
Datatype
boolean
Alias
- UMLS CUI-1
- C0851312
- UMLS CUI-2
- C3646033
Beschrijving
No previous chemotherapy or hormonal therapy (except for tamoxifen as described in the protocol) for this malignancy
Datatype
boolean
Alias
- UMLS CUI-1
- C3665472
- UMLS CUI-2
- C0279025
Beschrijving
Age >= 18 years
Datatype
boolean
Alias
- UMLS CUI-1
- C0001779
Beschrijving
CTC Performance status 0-1
Datatype
boolean
Alias
- UMLS CUI-1
- C0027625
- UMLS CUI-2
- C1518965
Beschrijving
Non-pregnant and non-nursing
Datatype
boolean
Alias
- UMLS CUI-1
- C0232973
- UMLS CUI-2
- C0006147
Beschrijving
No active congestive heart failure nor myocardial infarction within 6 months prior to registration
Datatype
boolean
Alias
- UMLS CUI-1
- C0018802
- UMLS CUI-2
- C0027051
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI-1
- C0242793
- UMLS CUI-2
- C0677898
Beschrijving
Willing to stop exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene
Datatype
boolean
Alias
- UMLS CUI-1
- C0600109
- UMLS CUI-2
- C1516999
- UMLS CUI-3
- C2746065
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI-1
- C0039286
- UMLS CUI-2
- C1444662
Beschrijving
Date tamoxifen started
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C3173309
- UMLS CUI-2
- C0039286
Beschrijving
Date tamoxifen discontinued
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C0039286
- UMLS CUI-2
- C2826748
Beschrijving
Meets ALL of the following laboratory criteria completed within 16 days before registration
Datatype
boolean
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0243161
Beschrijving
ANC >= 1000/mcL
Datatype
boolean
Alias
- UMLS CUI-1
- C0948762
- UMLS CUI-2
- C0439378
Beschrijving
Date obtained (ANC)
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C0948762
- UMLS CUI-2
- C1277697
Beschrijving
Platelets >= 100,000/mcL
Datatype
boolean
Alias
- UMLS CUI-1
- C0032181
- UMLS CUI-2
- C0439378
Beschrijving
Date obtained (Platelets)
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1277697
- UMLS CUI-2
- C0032181
Beschrijving
Creatinine <= 2.0 mg/dL
Datatype
boolean
Alias
- UMLS CUI-1
- C0201975
- UMLS CUI-2
- C0439269
Beschrijving
Date obtained (Creatinine)
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1277697
- UMLS CUI-2
- C0201975
Beschrijving
Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)
Datatype
boolean
Alias
- UMLS CUI-1
- C0201913
- UMLS CUI-2
- C0439269
Beschrijving
Date obtained (Total Bilirubin)
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1277697
- UMLS CUI-2
- C0201913
Beschrijving
ULN (Total Bilirubin)
Datatype
integer
Alias
- UMLS CUI-1
- C1519815
- UMLS CUI-2
- C0201913
Beschrijving
Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist
Similar models
INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.
- StudyEvent: CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST
C2603343 (UMLS CUI-2)
C0030692 (UMLS CUI-2)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0237753 (UMLS CUI-2)
C2607850 (UMLS CUI-2)
C0600091 (UMLS CUI-2)
C0740370 (UMLS CUI-2)
C0278601 (UMLS CUI-2)
C0278488 (UMLS CUI-3)
C0221928 (UMLS CUI-2)
C1314939 (UMLS CUI-3)
C0332167 (UMLS CUI-2)
C2371027 (UMLS CUI-3)
C0193867 (UMLS CUI-2)
C3646033 (UMLS CUI-2)
C0279025 (UMLS CUI-2)
C1518965 (UMLS CUI-2)
C0006147 (UMLS CUI-2)
C0027051 (UMLS CUI-2)
C0677898 (UMLS CUI-2)
C1516999 (UMLS CUI-2)
C2746065 (UMLS CUI-3)
C1444662 (UMLS CUI-2)
C3173309 (UMLS CUI-1)
C0039286 (UMLS CUI-2)
C0039286 (UMLS CUI-1)
C2826748 (UMLS CUI-2)
C0243161 (UMLS CUI-2)
C0439378 (UMLS CUI-2)
C0948762 (UMLS CUI-1)
C1277697 (UMLS CUI-2)
C0439378 (UMLS CUI-2)
C1277697 (UMLS CUI-1)
C0032181 (UMLS CUI-2)
C0439269 (UMLS CUI-2)
C1277697 (UMLS CUI-1)
C0201975 (UMLS CUI-2)
C0439269 (UMLS CUI-2)
C1277697 (UMLS CUI-1)
C0201913 (UMLS CUI-2)
C0201913 (UMLS CUI-2)