ID

16424

Description

Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01215162

Link

https://clinicaltrials.gov/show/NCT01215162

Keywords

Versions (1)
  1. 7/15/16 7/15/16 -
Uploaded on

July 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01215162

English

Eligibility Breast Cancer NCT01215162

1 forms  
Criteria
Description

Criteria

1. histologically proven primary invasive breast carcinoma.
Description

Invasive carcinoma of breast Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205225
2. tumor pathologically determined <= 5cm in diameter.
Description

Tumor size Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
3. single, discrete, well-defined primary tumor.
Description

primary tumor Well defined Discrete Single

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0442825
UMLS CUI [1,3]
C0443299
UMLS CUI [1,4]
C0205171
4. any micro-calcifications must be focal. a specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
Description

Microcalcification Focal | Specimen Radiographic | Lumpectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0521174
UMLS CUI [1,2]
C0205234
UMLS CUI [2,1]
C0370003
UMLS CUI [2,2]
C0444708
UMLS CUI [3]
C0740370
5. pathologically negative surgical margins.
Description

Negative Surgical Margin

Data type

boolean

Alias
UMLS CUI [1]
C1709157
6. axillary lymph node status can be determined by level i and ii lymph node dissection or sentinel lymph node sampling.
Description

Axillary lymph node Status | Excision of axillary lymph nodes | Sentinel Lymph Node Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0449438
UMLS CUI [2]
C0193867
UMLS CUI [3,1]
C1522495
UMLS CUI [3,2]
C0441621
7. ecog performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
contraindications:
Description

Medical contraindication

Data type

boolean

Alias
UMLS CUI [1]
C1301624
1. multicentric disease and/or diffuse malignant appearing microcalcifications.
Description

Disease Multicentric | Microcalcification Malignant Diffuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439743
UMLS CUI [2,1]
C0521174
UMLS CUI [2,2]
C0205282
UMLS CUI [2,3]
C0205219
2. evidence of metastatic breast cancer.
Description

Carcinoma breast stage IV Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0278488
UMLS CUI [1,2]
C0332120
3. axillary lymph node involvement.
Description

Axillary Lymph Node Involvement

Data type

boolean

Alias
UMLS CUI [1]
C0741343
4. pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
Description

Collagen-vascular disease Pre-existing | Rheumatoid Arthritis Requirement Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0262428
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021079
5. prior irradiation to the ara of planned radiation field.
Description

prior radiation therapy Area | Radiation Field Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205146
UMLS CUI [2,1]
C1882536
UMLS CUI [2,2]
C1301732
6. pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT01215162

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Invasive carcinoma of breast Primary
Item
1. histologically proven primary invasive breast carcinoma.
boolean
C0853879 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Tumor size Diameter
Item
2. tumor pathologically determined <= 5cm in diameter.
boolean
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
primary tumor Well defined Discrete Single
Item
3. single, discrete, well-defined primary tumor.
boolean
C0677930 (UMLS CUI [1,1])
C0442825 (UMLS CUI [1,2])
C0443299 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
Microcalcification Focal | Specimen Radiographic | Lumpectomy
Item
4. any micro-calcifications must be focal. a specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
boolean
C0521174 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0370003 (UMLS CUI [2,1])
C0444708 (UMLS CUI [2,2])
C0740370 (UMLS CUI [3])
Negative Surgical Margin
Item
5. pathologically negative surgical margins.
boolean
C1709157 (UMLS CUI [1])
Axillary lymph node Status | Excision of axillary lymph nodes | Sentinel Lymph Node Sampling
Item
6. axillary lymph node status can be determined by level i and ii lymph node dissection or sentinel lymph node sampling.
boolean
C0729594 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0193867 (UMLS CUI [2])
C1522495 (UMLS CUI [3,1])
C0441621 (UMLS CUI [3,2])
ECOG performance status
Item
7. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Medical contraindication
Item
contraindications:
boolean
C1301624 (UMLS CUI [1])
Disease Multicentric | Microcalcification Malignant Diffuse
Item
1. multicentric disease and/or diffuse malignant appearing microcalcifications.
boolean
C0012634 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C0521174 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C0205219 (UMLS CUI [2,3])
Carcinoma breast stage IV Evidence of
Item
2. evidence of metastatic breast cancer.
boolean
C0278488 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Axillary Lymph Node Involvement
Item
3. axillary lymph node involvement.
boolean
C0741343 (UMLS CUI [1])
Collagen-vascular disease Pre-existing | Rheumatoid Arthritis Requirement Therapeutic immunosuppression
Item
4. pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
boolean
C0262428 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021079 (UMLS CUI [2,3])
prior radiation therapy Area | Radiation Field Planned
Item
5. prior irradiation to the ara of planned radiation field.
boolean
C0279134 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1882536 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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